Lumbosacral Orthosis Suppliers
Limit companies to: Worldwide USA
VQ OrthoCare | Address: 18011 Mitchell South, Irvine, California 92614-6007, USA 
www.vqorthocare.com/orders | Send Inquiry | Phone: (800) 652-1135
FDA Registration: 2031823
Products: Knee Braces, Hand and Wrist Braces, Skin Closures, Knee Braces, Exercise Therapy kits, Orthopedic knee Braces, Adult Hand & Wrist Splints, ...
Vq OrthoCARE Wholesale offers caring services and supports orthopedic rehabilitation & surgical needs. We provide unparalleled patient support with patient care representatives and DME orthopedic tech more...
www.vqorthocare.com/orders | Send Inquiry | Phone: (800) 652-1135
FDA Registration: 2031823
Products: Knee Braces, Hand and Wrist Braces, Skin Closures, Knee Braces, Exercise Therapy kits, Orthopedic knee Braces, Adult Hand & Wrist Splints, ...
Vq OrthoCARE Wholesale offers caring services and supports orthopedic rehabilitation & surgical needs. We provide unparalleled patient support with patient care representatives and DME orthopedic tech more...
Orthomerica Products, Inc. | Address: #505, 31st Street, Newport Beach, California 92663, USA
www.orthomerica.com | Send Inquiry | Phone: +1-(949)-723-4500
FDA Registration: 1058152 Year Established: 1989 Annual Revenues: USD 10-25 Million Employee Count: ~90 Quality: ISO 9001, CE Certified
Products: Acetabular Liners, Hip Orthoses, Pediatric Orthoses, Cervicothoracic Lumbar Orthosis, Prefabricated Hip Orthoses, Bilateral Hip Orthoses, ...
Orthomerica Products, Inc. manufactures and markets prefabricated, semi-custom & custom orthoses. We are an ISO 9001, CE MARK certified company. We offer products like hip orthoses, low extremity orth more...
www.orthomerica.com | Send Inquiry | Phone: +1-(949)-723-4500
FDA Registration: 1058152 Year Established: 1989 Annual Revenues: USD 10-25 Million Employee Count: ~90 Quality: ISO 9001, CE Certified
Products: Acetabular Liners, Hip Orthoses, Pediatric Orthoses, Cervicothoracic Lumbar Orthosis, Prefabricated Hip Orthoses, Bilateral Hip Orthoses, ...
Orthomerica Products, Inc. manufactures and markets prefabricated, semi-custom & custom orthoses. We are an ISO 9001, CE MARK certified company. We offer products like hip orthoses, low extremity orth more...
Mizuho OSI | Address: 30031 Ahern Avenue, Union City, California 94587-1234, USA
www.osiosi.com | Send Inquiry | Phone: +1-(510)-429-1500, 800-777-4674
FDA Registration: 2921578 Year Established: 1978 Annual Revenues: USD 50-100 Million Employee Count: ~270 Quality: ISO 9001, CE Certified
Products: Radiolucent Spinal Frame, Fracture Tables, Casting Stands, General Medical Supplies, Elastic Bandages (FDA Code: FQM), Casting Materials and Equipment, Casting Stands, ...
Mizuho OSI designs & manufactures medical products. Our products include surgical tables, table accessories, traction systems, pressure management, and hand surgery. Our Advanced Control Pad System&tr more...
www.osiosi.com | Send Inquiry | Phone: +1-(510)-429-1500, 800-777-4674
FDA Registration: 2921578 Year Established: 1978 Annual Revenues: USD 50-100 Million Employee Count: ~270 Quality: ISO 9001, CE Certified
Products: Radiolucent Spinal Frame, Fracture Tables, Casting Stands, General Medical Supplies, Elastic Bandages (FDA Code: FQM), Casting Materials and Equipment, Casting Stands, ...
Mizuho OSI designs & manufactures medical products. Our products include surgical tables, table accessories, traction systems, pressure management, and hand surgery. Our Advanced Control Pad System&tr more...
DJ Orthopedics Inc. | Address: 2985 Scott Street, Vista, California 92081, USA
www.djortho.com | Phone: +1-(760)-727-1280, (800)-321-9549
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Splints, Forceps (FDA Code: HTD), External Bone Growth Stimulators, Bone Rasps (FDA Code: HTR), Surgical Helmet Systems, Ankle Braces, ...
DJ Orthopedics, Inc. is a global medical device company specializing in rehabilitation and regeneration products for the non-operative orthopedic & spine markets. We offer products like ankle & knee b more...
www.djortho.com | Phone: +1-(760)-727-1280, (800)-321-9549
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Splints, Forceps (FDA Code: HTD), External Bone Growth Stimulators, Bone Rasps (FDA Code: HTR), Surgical Helmet Systems, Ankle Braces, ...
DJ Orthopedics, Inc. is a global medical device company specializing in rehabilitation and regeneration products for the non-operative orthopedic & spine markets. We offer products like ankle & knee b 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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
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: Splints, Hip Orthoses, Pediatric Orthoses, Orthoses Cervico-Thoracic Braces, Head Cervicothoracic Orthoses, Orthoses, Foot Braces, ...
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: Splints, Hip Orthoses, Pediatric Orthoses, Orthoses Cervico-Thoracic Braces, Head Cervicothoracic Orthoses, Orthoses, Foot Braces, ...
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...
Zimmer, Inc. | Address: P.O. Box 708 ,1800 West Center Street, Warsaw, Indiana 46581-0708, USA
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Spreaders, Silicone Tubing, Dressing Forceps, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni more...
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Spreaders, Silicone Tubing, Dressing Forceps, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni 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: Heat or Cold Packs, Blades, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
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: Heat or Cold Packs, Blades, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
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, Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Thoracic Orthosis, Brace (FDA Code: IPT), ...
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, Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Thoracic Orthosis, Brace (FDA Code: IPT), ...
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, Orthopedic Back Braces, ...
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, Orthopedic Back Braces, ...
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...
Alimed, Inc. | Address: 297 High Street, Dedham, Massachusetts 02026, USA
www.alimed.com | Send Inquiry | Phone: +001-(800)-225-2610
FDA Registration: 1218386 Employee Count: ~180 Quality: ISO, CE Certified
Products: Masks & Breathing Bags, Hypodermic Syringes, Bodyfat Analyzers, Spirometers, Disposable Examination Gloves, Furniture & Storage, ...
Alimed, Inc. is a manufacturer and supplier of pre-formed orthoses, alarms for fall management, cushions, diagnostic imaging & operating room accessories, orthopedic rehabilitation equipment, and ergo more...
www.alimed.com | Send Inquiry | Phone: +001-(800)-225-2610
FDA Registration: 1218386 Employee Count: ~180 Quality: ISO, CE Certified
Products: Masks & Breathing Bags, Hypodermic Syringes, Bodyfat Analyzers, Spirometers, Disposable Examination Gloves, Furniture & Storage, ...
Alimed, Inc. is a manufacturer and supplier of pre-formed orthoses, alarms for fall management, cushions, diagnostic imaging & operating room accessories, orthopedic rehabilitation equipment, and ergo 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, Cervicothoracic Lumbar Orthosis, Orthoses, Lumbosacral Braces, ...
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, Cervicothoracic Lumbar Orthosis, Orthoses, Lumbosacral Braces, ...
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 Forceps, Scalp Hooks, Clips and Appliers, Dissectors, Micro Curettes, Gastroenterologic Needle Holder (FDA Code: FHQ), Rongeurs, ...
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 Forceps, Scalp Hooks, Clips and Appliers, Dissectors, Micro Curettes, Gastroenterologic Needle Holder (FDA Code: FHQ), Rongeurs, ...
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...
Bird & Cronin Inc. | Address: 1200 Trapp Road, Eagan, Minnesota 55121, USA
www.birdcronin.com | Send Inquiry | Phone: +1-(800)-328-1095
FDA Registration: 2182345
Products: Splints, Cast Boots, Ankle Braces, Foot Braces, Shoulder Braces, Knee Braces, ...
Bird and Cronin Inc. manufactures patient footwear, orthopedic soft goods and specialty patient care products. We offer products like cervical, upper extremities, lumbar/low back, lower extremities, c more...
www.birdcronin.com | Send Inquiry | Phone: +1-(800)-328-1095
FDA Registration: 2182345
Products: Splints, Cast Boots, Ankle Braces, Foot Braces, Shoulder Braces, Knee Braces, ...
Bird and Cronin Inc. manufactures patient footwear, orthopedic soft goods and specialty patient care products. We offer products like cervical, upper extremities, lumbar/low back, lower extremities, c more...
Corflex, Inc. | Address: 669 East Industrial Park Drive, Manchester, New Hampshire 03109, USA
www.corflex.com | Send Inquiry | Phone: +1-(603)-623.3344
FDA Registration: 1218997 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: CE Certified
Products: Splints, Ankle Braces, Elbow Braces, Foot Braces, Humeral Splints, Shoulder Braces, ...
Corflex, Inc. manufactures & distributes orthopedic rehabilitation, sports medicine and orthotic products. We produce a broad range of over 250 products. We offer a comprehensive line of sports medici more...
www.corflex.com | Send Inquiry | Phone: +1-(603)-623.3344
FDA Registration: 1218997 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: CE Certified
Products: Splints, Ankle Braces, Elbow Braces, Foot Braces, Humeral Splints, Shoulder Braces, ...
Corflex, Inc. manufactures & distributes orthopedic rehabilitation, sports medicine and orthotic products. We produce a broad range of over 250 products. We offer a comprehensive line of sports medici 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: Orthopedic Cushions, Splints, Ankle Braces, Elbow Braces, Knee Braces, Hand and Wrist 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: Orthopedic Cushions, Splints, Ankle Braces, Elbow Braces, Knee Braces, Hand and Wrist 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...
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: Orthopedic Cushions, Cast Boots, Ankle Braces, Finger Splints, Latex Disposable Gloves, Latex Gloves, ...
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: Orthopedic Cushions, Cast Boots, Ankle Braces, Finger Splints, Latex Disposable Gloves, Latex Gloves, ...
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...
Wright Medical Technology, Inc. | Address: 5677 Airline Road, Arlington, Tennessee 38002, USA
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for more...
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for more...
Kenad SG Medical Inc. | Address: 2692 Huntley DR, Memphis, Tennessee 38132, USA
kenad.com | Send Inquiry | Phone: +001-(901)-345-0606
FDA Registration: 1054236
Products: Straps, Slings & Immobilizers, Cervicothoracic Lumbar Orthosis, Arm Slings (FDA Code: ILI), Shoulder Abduction Pillow, Patella Tendon Strap, Disposable Arm Slings, ...
Kenad Sg Medical Inc. develops a wide range of knee immobilizers, knee braces & supports, ankle braces & supports, cast room products, elbow supports wrist splints, rib belts abdominal binders, lumbos more...
kenad.com | Send Inquiry | Phone: +001-(901)-345-0606
FDA Registration: 1054236
Products: Straps, Slings & Immobilizers, Cervicothoracic Lumbar Orthosis, Arm Slings (FDA Code: ILI), Shoulder Abduction Pillow, Patella Tendon Strap, Disposable Arm Slings, ...
Kenad Sg Medical Inc. develops a wide range of knee immobilizers, knee braces & supports, ankle braces & supports, cast room products, elbow supports wrist splints, rib belts abdominal binders, lumbos 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, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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...
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FDA Code / Regulation: IPY / 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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