Cervical Thoracic Orthosis Suppliers
Limit companies to: Worldwide USA
Aspen Medical Products, Inc. | Address: 6481 Oak Canyon, Irvine, California 92618-5202, USA 
www.aspenmp.com | Send Inquiry | Phone: +1-(949)-681-0200, (800)-848-7455
FDA Registration: 2030775
Products: Back Braces & Supports, Cervicothoracic Bracing System, Cervicothoracic Lumbar Orthosis, Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Thoracic Orthosis, Brace (FDA Code: IPT), ...
Aspen Medical Products, Inc. creates, produces & distributes quality immobilization devices that improve patient care. We offer cervico thoracic bracing & lumbosacral bracing. Our Aspen® pediatric more...
www.aspenmp.com | Send Inquiry | Phone: +1-(949)-681-0200, (800)-848-7455
FDA Registration: 2030775
Products: Back Braces & Supports, Cervicothoracic Bracing System, Cervicothoracic Lumbar Orthosis, Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Thoracic Orthosis, Brace (FDA Code: IPT), ...
Aspen Medical Products, Inc. creates, produces & distributes quality immobilization devices that improve patient care. We offer cervico thoracic bracing & lumbosacral bracing. Our Aspen® pediatric more...
Hospital Marketing Services Co., Inc. | Address: PO Box 1217, 162 Great Hill Road, Naugatuck, Connecticut 06770-1217, USA
www.hmsmedical.com | Send Inquiry | Phone: +1-(800)-786-5094
Employee Count: ~50 Quality: CE Certified
Products: Heat or Cold Packs, Scalpels, Surgical Blades, Surgical Scalpels, Suture Needles, Disposable Scalpels, ...
Hospital Marketing Services Co., Inc. is a source for instant thermal products for hot & cold therapies, as well as skin markers, suture needles, scalpels, surgical blades, thermal binders and abdomin more...
www.hmsmedical.com | Send Inquiry | Phone: +1-(800)-786-5094
Employee Count: ~50 Quality: CE Certified
Products: Heat or Cold Packs, Scalpels, Surgical Blades, Surgical Scalpels, Suture Needles, Disposable Scalpels, ...
Hospital Marketing Services Co., Inc. is a source for instant thermal products for hot & cold therapies, as well as skin markers, suture needles, scalpels, surgical blades, thermal binders and abdomin more...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
Restorative Care of America, Inc. | Address: 12221 33rd Street North, St. Petersburg, Florida 33716, USA
www.rcai.com | Send Inquiry | Phone: +1-(727)-573-1595, (800)-627-1595
FDA Registration: 1051118 Year Established: 1975 Annual Revenues: USD 5-10 Million Employee Count: ~90 Quality: ISO 9001, CE Certified
Products: Ankle & Foot Orthoses, Arm & Shoulder Orthoses, Braces & Orthoses, Ankle Foot Orthoses, Elbow & Shoulder Orthoses, Back Orthoses, ...
Restorative Care of America, Inc. manufactures orthopedic and rehabilitative orthoses used in the treatment of conditions associated with traumatic injuries, chronic disease, post surgical procedures, more...
www.rcai.com | Send Inquiry | Phone: +1-(727)-573-1595, (800)-627-1595
FDA Registration: 1051118 Year Established: 1975 Annual Revenues: USD 5-10 Million Employee Count: ~90 Quality: ISO 9001, CE Certified
Products: Ankle & Foot Orthoses, Arm & Shoulder Orthoses, Braces & Orthoses, Ankle Foot Orthoses, Elbow & Shoulder Orthoses, Back Orthoses, ...
Restorative Care of America, Inc. manufactures orthopedic and rehabilitative orthoses used in the treatment of conditions associated with traumatic injuries, chronic disease, post surgical procedures, more...
Biomet, Inc | Address: PO Box 587, Warsaw, Indiana 46581-0587, USA
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
Tempico, Inc. | Address: 1700 West Church Street, Suite C, Hammond, Louisiana 70401, USA
www.tempico.com | Send Inquiry | Phone: +1-(985)-429-9929, 800-728-9006
FDA Registration: 1721293
Products: Electromedical Biofeedback Devices, Medical Waste Processing System, Rotoclaver System, Biofeedback Device (FDA Code: HCC), External Functional Neuromuscular Stimulator (FDA Code: GZI), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), ...
Tempico, Inc. produces & distributes the Rotoclave® medical processing systems to medical waste generators such as hospitals and laboratories. Our Rotoclave® technology offers the opportunity more...
www.tempico.com | Send Inquiry | Phone: +1-(985)-429-9929, 800-728-9006
FDA Registration: 1721293
Products: Electromedical Biofeedback Devices, Medical Waste Processing System, Rotoclaver System, Biofeedback Device (FDA Code: HCC), External Functional Neuromuscular Stimulator (FDA Code: GZI), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), ...
Tempico, Inc. produces & distributes the Rotoclave® medical processing systems to medical waste generators such as hospitals and laboratories. Our Rotoclave® technology offers the opportunity more...
Boston Brace International | Address: 20 Ledin Drive, Avon, Massachusetts 02322, USA
www.bostonbrace.com | Send Inquiry | Phone: +1-(508)-588-6060, (800)-262-2235
FDA Registration: 3001967835 Year Established: 1952 Annual Revenues: < USD 1 Million Employee Count: ~40
Products: Shoulder Braces, Hip Orthoses, Lumbosacral Braces, Straps, Slings & Immobilizers, Wrist/Arm/Shoulder Braces & Supports, Prefabricated Hip Orthoses, ...
Boston Brace International, Inc. designs and manufactures medical & sports bracing products for prevention, rehabilitation & correction. We offer products such as scoliosis, boston band, dynamic movem more...
www.bostonbrace.com | Send Inquiry | Phone: +1-(508)-588-6060, (800)-262-2235
FDA Registration: 3001967835 Year Established: 1952 Annual Revenues: < USD 1 Million Employee Count: ~40
Products: Shoulder Braces, Hip Orthoses, Lumbosacral Braces, Straps, Slings & Immobilizers, Wrist/Arm/Shoulder Braces & Supports, Prefabricated Hip Orthoses, ...
Boston Brace International, Inc. designs and manufactures medical & sports bracing products for prevention, rehabilitation & correction. We offer products such as scoliosis, boston band, dynamic movem more...
Becker Orthopedic | Address: 635 Executive Drive, Troy, Michigan 48083-4576, USA
www.beckerorthopedic.com | Send Inquiry | Phone: +1-(248)-588-7480, (800)-521-2192
FDA Registration: 1824252
Products: Lower Extremity Splints, Lumbosacral Braces, Cervico-Thoracic Braces, Orthoses Cervico-Thoracic Braces, Orthoses, Lumbosacral Braces, Lumbar Orthosis, Brace (FDA Code: IQE), ...
Becker Orthopedic provides orthotic components and central fabrication services. We specialize in rotational control lower extremity laminated orthoses. We deliver a complete lower limb, thermoplastic more...
www.beckerorthopedic.com | Send Inquiry | Phone: +1-(248)-588-7480, (800)-521-2192
FDA Registration: 1824252
Products: Lower Extremity Splints, Lumbosacral Braces, Cervico-Thoracic Braces, Orthoses Cervico-Thoracic Braces, Orthoses, Lumbosacral Braces, Lumbar Orthosis, Brace (FDA Code: IQE), ...
Becker Orthopedic provides orthotic components and central fabrication services. We specialize in rotational control lower extremity laminated orthoses. We deliver a complete lower limb, thermoplastic more...
PMT Corporation | Address: 1500 Park Road, Chanhassen, Minnesota 55317, USA
www.pmtcorp.com | Send Inquiry | Phone: +1-(952)-470-0866, 800-626-5463
FDA Registration: 2182979 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 13485, CE Certified
Products: Bipolar Electrode Cables, Adapters & Connectors, Neonatal Temperature Probe Adapter, Back Orthoses, Adult Skin Temperature Probes, Adult Rectal Temperature Probes, Battery-Operated Operating Headlamp (FDA Code: HPP), ...
PMT Corporation manufactures products for neurosurgery, orthopaedics, plastic, and reconstructive surgery. We are accredited with ISO 13485: 2003 certification. All our products are FDA approved. Our more...
www.pmtcorp.com | Send Inquiry | Phone: +1-(952)-470-0866, 800-626-5463
FDA Registration: 2182979 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 13485, CE Certified
Products: Bipolar Electrode Cables, Adapters & Connectors, Neonatal Temperature Probe Adapter, Back Orthoses, Adult Skin Temperature Probes, Adult Rectal Temperature Probes, Battery-Operated Operating Headlamp (FDA Code: HPP), ...
PMT Corporation manufactures products for neurosurgery, orthopaedics, plastic, and reconstructive surgery. We are accredited with ISO 13485: 2003 certification. All our products are FDA approved. Our more...
SAI Therapeutic Brands | Address: 3960 Rosslyn Drive, Cincinnati, Ohio 45209-1195, USA
surgicalappliance.com | Send Inquiry | Phone: +001-(800)-888-0458
Year Established: 1893 Annual Revenues: USD 25-50 Million Employee Count: ~350
Products: Ankle Braces, Elbow Braces, Knee Braces, Hand and Wrist Braces, Lumbosacral Braces, Skin Closures, Knee Braces, ...
SAI Therapeutic Brands deals with healthcare products. Our products are divided into four major brand categories such as Truform therapeutic compression hosiery, Truform OTC orthotics & prosthetics, A more...
surgicalappliance.com | Send Inquiry | Phone: +001-(800)-888-0458
Year Established: 1893 Annual Revenues: USD 25-50 Million Employee Count: ~350
Products: Ankle Braces, Elbow Braces, Knee Braces, Hand and Wrist Braces, Lumbosacral Braces, Skin Closures, Knee Braces, ...
SAI Therapeutic Brands deals with healthcare products. Our products are divided into four major brand categories such as Truform therapeutic compression hosiery, Truform OTC orthotics & prosthetics, A more...
Oakworks, Inc, | Address: 923 East Wellspring Road, New Freedom, Pennsylvania 17349, USA
www.oakworks.com | Send Inquiry | Phone: +1-(717)-235-6807, 800-916-4612
FDA Registration: 2529571 Year Established: 1977 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: CE Certified
Products: Maintenance & Repair, Sterilizer Repair Service, Exam Chair Repair Service, Transport Stretchers Repair Service, Distillation Units Repair Service, Radiology Unit Repair Service, ...
Oakworks® Medical Equipment for radiology & fluoroscopy offers radiolucent patient positioning for diagnostic & surgical procedures with special consideration toward optimum patient comfort and ma more...
www.oakworks.com | Send Inquiry | Phone: +1-(717)-235-6807, 800-916-4612
FDA Registration: 2529571 Year Established: 1977 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: CE Certified
Products: Maintenance & Repair, Sterilizer Repair Service, Exam Chair Repair Service, Transport Stretchers Repair Service, Distillation Units Repair Service, Radiology Unit Repair Service, ...
Oakworks® Medical Equipment for radiology & fluoroscopy offers radiolucent patient positioning for diagnostic & surgical procedures with special consideration toward optimum patient comfort and ma more...
Bilt-rite Orthopedics Safety, Inc. | Address: 3940 Nebraska Street, Newportville, Pennsylvania 19056, USA
www.biltriteinc.com | Send Inquiry | Phone: +1-(215)-785-6980
FDA Registration: 3006189705
Products: Ankle Braces, Aluminum Forearm Crutches, Ankle Brace Lock (ABL), Abdominal Binders (FDA Code: FSD), Abdominal Supports, Adjustable Folding Cane, ...
Bilt-rite Orthopedics Safety, Inc. designs & develops orthopedics, sports medicines, bracing products, occupational, ergonomic supports & a complete line of high visibility safety gear. Our products i more...
www.biltriteinc.com | Send Inquiry | Phone: +1-(215)-785-6980
FDA Registration: 3006189705
Products: Ankle Braces, Aluminum Forearm Crutches, Ankle Brace Lock (ABL), Abdominal Binders (FDA Code: FSD), Abdominal Supports, Adjustable Folding Cane, ...
Bilt-rite Orthopedics Safety, Inc. designs & develops orthopedics, sports medicines, bracing products, occupational, ergonomic supports & a complete line of high visibility safety gear. Our products i more...
DeRoyal Industries | Address: 200 DeBusk Lane, Powell, Tennessee 37849, USA
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
Caguas Orthopedic Center, Inc. | Address: Ff4, Calle 11, 4th Secc., Villa Del Rey, Caguas 00625, USA
Phone: +1-(787)-744-2325
Products: Cervical Thoracic Orthosis (FDA Code: IPT), Cervical Orthosis (FDA Code: IQK), External Component Thigh Socket Prosthesis (FDA Code: ISS), Knee Cage (FDA Code: ITM), Limb Brace Orthosis (FDA Code: IQI), Hand/wrist Mechanical Assembly (FDA Code: KFT), ...
Caguas Orthopedic Center, Inc. provides orthosis, limb brace, orthosis cervical, cage, knee, orthosis lumbar, upper extremity prosthesis, lower extremity prosthesis, and orthosis thoracic. more...
Phone: +1-(787)-744-2325
Products: Cervical Thoracic Orthosis (FDA Code: IPT), Cervical Orthosis (FDA Code: IQK), External Component Thigh Socket Prosthesis (FDA Code: ISS), Knee Cage (FDA Code: ITM), Limb Brace Orthosis (FDA Code: IQI), Hand/wrist Mechanical Assembly (FDA Code: KFT), ...
Caguas Orthopedic Center, Inc. provides orthosis, limb brace, orthosis cervical, cage, knee, orthosis lumbar, upper extremity prosthesis, lower extremity prosthesis, and orthosis thoracic. more...
American Orthopedic Supply Co., Inc. | Address: 37017 State Hwy. 79, Cleveland, Alabama 35049, USA
www.americanorthopedicsupply.com | Phone: +1-(205)-274-7137
Products: Arm Slings (FDA Code: ILI), Disposable Arm Slings, Envelope Arm Sling, Double Pouch Arm Sling, Arm Sling Strap Pads, Arm Sling Immobilizer, ...
American Orthopedic Supply Co., Inc. specializes in the supply of all types of medical laboratory and hospital equipment, acupuncture products, and also in the sale of used medical equipment. more...
www.americanorthopedicsupply.com | Phone: +1-(205)-274-7137
Products: Arm Slings (FDA Code: ILI), Disposable Arm Slings, Envelope Arm Sling, Double Pouch Arm Sling, Arm Sling Strap Pads, Arm Sling Immobilizer, ...
American Orthopedic Supply Co., Inc. specializes in the supply of all types of medical laboratory and hospital equipment, acupuncture products, and also in the sale of used medical equipment. more...
Ossur Americas | Address: 742 Pancho Rd., Camarillo, California 93012, USA
www.shopossur.com | Phone: +1-(800)-521-0601
FDA Registration: 2020250
Products: Cervical Collars, Ankle Braces & Supports, Back Supports, Arm Slings (FDA Code: ILI), Clavicle Splint (FDA Code: IQJ), Clavicle Supports, ...
Ossur Americas specializes in providing orthopedic products and medical supplies. We provide braces & supports, casting & splinting, wound care products, podiatry supplies and surgical supplies. Our A more...
www.shopossur.com | Phone: +1-(800)-521-0601
FDA Registration: 2020250
Products: Cervical Collars, Ankle Braces & Supports, Back Supports, Arm Slings (FDA Code: ILI), Clavicle Splint (FDA Code: IQJ), Clavicle Supports, ...
Ossur Americas specializes in providing orthopedic products and medical supplies. We provide braces & supports, casting & splinting, wound care products, podiatry supplies and surgical supplies. Our A more...
Hosmer Dorrance Corp. | Address: 561 Division St., Campbell, California 95008, USA
www.hosmer.com | Phone: +1-(408)-379-5151
Products: Specialty Patient Examination Glove (FDA Code: LZC), External Ankle Brace (FDA Code: ITW), External Brace Hip Joint (FDA Code: ITS), External Brace Knee Joint (FDA Code: ITQ), External Component Thigh Socket Prosthesis (FDA Code: ISS), External Limb Component, Ankle/Foot (FDA Code: ISH), ...
Hosmer Dorrance Corp. specializes in prosthetics. Our Stance flexion device adds adjustable stance flexion to most endoskeletal knee shin systems like weight activated locking knee , single axis frict more...
www.hosmer.com | Phone: +1-(408)-379-5151
Products: Specialty Patient Examination Glove (FDA Code: LZC), External Ankle Brace (FDA Code: ITW), External Brace Hip Joint (FDA Code: ITS), External Brace Knee Joint (FDA Code: ITQ), External Component Thigh Socket Prosthesis (FDA Code: ISS), External Limb Component, Ankle/Foot (FDA Code: ISH), ...
Hosmer Dorrance Corp. specializes in prosthetics. Our Stance flexion device adds adjustable stance flexion to most endoskeletal knee shin systems like weight activated locking knee , single axis frict more...
Cascade Orthopedic Supply, Inc. | Address: 2638 Aztec Drive, Chico, California 95928, USA
www.cascade-usa.com | Phone: +1-(530)-879-1500/800-888-0865
FDA Registration: 2950684
Products: Acetabular Liners, Cast Liners, Hip Orthoses, Casting Materials and Equipment, Casting Stands, Post-Operative Hip Orthoses, Pediatric Hip Orthoses, ...
Cascade Orthopedic Supply is a distributor of medical equipment. We focused on prosthetics, orthotistics and foot care specialists. We market ankle joints, cervical, spinal and stirrups. Our new produ more...
www.cascade-usa.com | Phone: +1-(530)-879-1500/800-888-0865
FDA Registration: 2950684
Products: Acetabular Liners, Cast Liners, Hip Orthoses, Casting Materials and Equipment, Casting Stands, Post-Operative Hip Orthoses, Pediatric Hip Orthoses, ...
Cascade Orthopedic Supply is a distributor of medical equipment. We focused on prosthetics, orthotistics and foot care specialists. We market ankle joints, cervical, spinal and stirrups. Our new produ more...
Circular Traction Supply, Inc. | Address: 7602 Talbert Ave, Unit 9, Huntington Beach, California 92648, USA
www.circulartraction.com | Send Inquiry | Phone: +1-(714)-847-8334, 800-247-6535
FDA Registration: 3005083774
Products: Cervical Collars, Cervical Thoracic Orthosis (FDA Code: IPT), Non-Powered Traction Apparatus (FDA Code: HST), Cervical Orthosis (FDA Code: IQK), Exercise Component (FDA Code: IOD), Powered Traction Equipment (FDA Code: ITH), ...
Circular Traction Supply, Inc. provides extension traction oriented products. We have devised a wearable spinal remodeling brace (SRBrace TM)™ and have developed the use of these wearable spinal more...
www.circulartraction.com | Send Inquiry | Phone: +1-(714)-847-8334, 800-247-6535
FDA Registration: 3005083774
Products: Cervical Collars, Cervical Thoracic Orthosis (FDA Code: IPT), Non-Powered Traction Apparatus (FDA Code: HST), Cervical Orthosis (FDA Code: IQK), Exercise Component (FDA Code: IOD), Powered Traction Equipment (FDA Code: ITH), ...
Circular Traction Supply, Inc. provides extension traction oriented products. We have devised a wearable spinal remodeling brace (SRBrace TM)™ and have developed the use of these wearable spinal more...
Reach Global Industries, Inc. | Address: 8 Corporate Park, Suite 300, Irvine, California 92606, USA
www.rgihealthcare.com | Send Inquiry | Phone: +1-(949)-309-2958, 888-518-8389
FDA Registration: 2031343 Year Established: 1997 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Disposable Urine Bags, Drainage Systems, Personal Care Products, Urinary Drainage Bag, Urinals (FDA Code: FNP), Mask, ...
Reach Global Industries, Inc. offers product manufacturing and distribution services in the areas of consumer personal hygiene, injection molded OEM plastic parts & medical products. Our healthcare di more...
www.rgihealthcare.com | Send Inquiry | Phone: +1-(949)-309-2958, 888-518-8389
FDA Registration: 2031343 Year Established: 1997 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Disposable Urine Bags, Drainage Systems, Personal Care Products, Urinary Drainage Bag, Urinals (FDA Code: FNP), Mask, ...
Reach Global Industries, Inc. offers product manufacturing and distribution services in the areas of consumer personal hygiene, injection molded OEM plastic parts & medical products. Our healthcare di more...
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FDA Code / Regulation: IPT / 890.3490
A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.
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