Knee Cage Suppliers
Limit companies to: Worldwide USA
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...
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...
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...
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...
Kingsley Mfg. Co. | Address: 1984 Placentia Ave., Costa Mesa, California 92627-3421, USA
www.oandp.com/kingsley | Send Inquiry | Phone: +1-(714)-645-4401, 800-854-3479
FDA Registration: 2021683 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Cervical Collars, Compression Hosiery, Casting Tapes, Clavicle Strap, Carpal Gel Sleeve, Ankle Support, ...
Kingsley Mfg. Co. provides a complete product line for orthotics & prosthetics. Our product catalog includes Becker orthopedic, prosthetic liners & suspension, foot management equipment, and lower & u more...
www.oandp.com/kingsley | Send Inquiry | Phone: +1-(714)-645-4401, 800-854-3479
FDA Registration: 2021683 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Cervical Collars, Compression Hosiery, Casting Tapes, Clavicle Strap, Carpal Gel Sleeve, Ankle Support, ...
Kingsley Mfg. Co. provides a complete product line for orthotics & prosthetics. Our product catalog includes Becker orthopedic, prosthetic liners & suspension, foot management equipment, and lower & u more...
DJO Incorporated | Address: 1430 Decision Street, Vista, California 92081-8553, USA
www.djoglobal.com | Phone: +1-(760)-727-1280, 800-336-6569
FDA Registration: 2020737 Year Established: 1978 Employee Count: ~4000
Products: Ankle Braces, Knee Braces, Cuffing System, Orthopedic knee Braces, Orthopaedic Implants, Ankle Braces & Supports, ...
DJO Incorporated is a provider of orthopedic devices. We offer a wide range of products used for rehabilitation, pain management and physical therapy. We also develop, manufacture and distribute a bro more...
www.djoglobal.com | Phone: +1-(760)-727-1280, 800-336-6569
FDA Registration: 2020737 Year Established: 1978 Employee Count: ~4000
Products: Ankle Braces, Knee Braces, Cuffing System, Orthopedic knee Braces, Orthopaedic Implants, Ankle Braces & Supports, ...
DJO Incorporated is a provider of orthopedic devices. We offer a wide range of products used for rehabilitation, pain management and physical therapy. We also develop, manufacture and distribute a bro more...
Tartan Orthopedics, Ltd. | Address: 10651 Irma Drive, Unit C, Northglenn, Colorado 80233, USA
www.tartanortho.com | Send Inquiry | Phone: +1-(303)-287-1456, 888-287-1456
Year Established: 1974 Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Cervical Collars, Adult Foot & Ankle Splints, Abdominal Binders (FDA Code: FSD), Acromioclavicular Splint, Clavicle Strap, Ankle Wraps, ...
Tartan Orthopedics, Ltd. provides abdominal binders, acromioclavicular splints, ankle splints, wraps, supports for the back,trochanter, lumbar, sacral and dorsal lumbar regions.We also supply cervical more...
www.tartanortho.com | Send Inquiry | Phone: +1-(303)-287-1456, 888-287-1456
Year Established: 1974 Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Cervical Collars, Adult Foot & Ankle Splints, Abdominal Binders (FDA Code: FSD), Acromioclavicular Splint, Clavicle Strap, Ankle Wraps, ...
Tartan Orthopedics, Ltd. provides abdominal binders, acromioclavicular splints, ankle splints, wraps, supports for the back,trochanter, lumbar, sacral and dorsal lumbar regions.We also supply cervical more...
U.S. Orthotics, Inc. | Address: 8605 Palm River Road, Tampa, Florida 33619-4317, USA
www.usorthotics.com | Send Inquiry | Phone: +1-(813)-621-7797, 800-825-5228
FDA Registration: 1043533 Year Established: 1979 Annual Revenues: USD 1-5 Million Employee Count: ~50
Products: Elastic Ankle Support, Adjustable Ankle Support, Air Ankle Support, Basic Ankle Support, Double-Strap Ankle Support, Ankle Support, ...
U.S. Orthotics, Inc. specializes in the design, manufacturing, and servicing of orthopedic products. We offer traditional chair back orthosis with rigid anterior panel and soft foam lined rigid poster more...
www.usorthotics.com | Send Inquiry | Phone: +1-(813)-621-7797, 800-825-5228
FDA Registration: 1043533 Year Established: 1979 Annual Revenues: USD 1-5 Million Employee Count: ~50
Products: Elastic Ankle Support, Adjustable Ankle Support, Air Ankle Support, Basic Ankle Support, Double-Strap Ankle Support, Ankle Support, ...
U.S. Orthotics, Inc. specializes in the design, manufacturing, and servicing of orthopedic products. We offer traditional chair back orthosis with rigid anterior panel and soft foam lined rigid poster more...
Orthotic & Prosthetic Lab, Inc. | Address: 748 Marshall Ave., St. Louis, Missouri 63119, USA
www.oandplabinc.com | Send Inquiry | Phone: +1-(314)-968-8555
Products: Cervicothoracic Lumbar Orthosis, Arm Support Extender:, Arm Supports (FDA Code: IOY), Cranial Orthosis (FDA Code: MVA), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), ...
Orthotic & Prosthetic Lab, Inc. produces custom made orthotic, prosthetic, pedorthic devices and mastectomy products. The design elements of the LuXon Max DP foot system offer users a comfortable, liv more...
www.oandplabinc.com | Send Inquiry | Phone: +1-(314)-968-8555
Products: Cervicothoracic Lumbar Orthosis, Arm Support Extender:, Arm Supports (FDA Code: IOY), Cranial Orthosis (FDA Code: MVA), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), ...
Orthotic & Prosthetic Lab, Inc. produces custom made orthotic, prosthetic, pedorthic devices and mastectomy products. The design elements of the LuXon Max DP foot system offer users a comfortable, liv more...
Top Medical Corp. | Address: 2f, No. 114, Bai-Ma Street, Chung Li City 320, Taiwan 
Phone: +886-(757)-2240177
FDA Registration: 3007127364
Products: Arm Supports (FDA Code: IOY), Cast Shoe (FDA Code: IPG), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), Corrective Shoe Orthosis (FDA Code: KNP), External Brace Hip Joint (FDA Code: ITS), ...
Top Medical Corp. deals with arm supports, cast shoes, cervical orthosis, corrective shoe orthosis, external ankle braces and external brace hip joints. more...
Phone: +886-(757)-2240177
FDA Registration: 3007127364
Products: Arm Supports (FDA Code: IOY), Cast Shoe (FDA Code: IPG), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), Corrective Shoe Orthosis (FDA Code: KNP), External Brace Hip Joint (FDA Code: ITS), ...
Top Medical Corp. deals with arm supports, cast shoes, cervical orthosis, corrective shoe orthosis, external ankle braces and external brace hip joints. more...
Orthoplus International Corporation Limited | Address: 7f-1, No.39, Shaw Nien Street, Hsinchu 300, Taiwan
Phone: +886-(3)-5281210
FDA Registration: 3006617872
Products: Lumbar Orthosis, Brace (FDA Code: IQE), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Knee Cage (FDA Code: ITM), Limb & Truncal Orthosis (FDA Code: MRI), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
Orthoplus International Corporation Limited offers health-care products such as arm slings, clavicle splints, external ankle braces, limb brace orthosis, rigid cervical-thoracic orthosis, knee cages, more...
Phone: +886-(3)-5281210
FDA Registration: 3006617872
Products: Lumbar Orthosis, Brace (FDA Code: IQE), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Knee Cage (FDA Code: ITM), Limb & Truncal Orthosis (FDA Code: MRI), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
Orthoplus International Corporation Limited offers health-care products such as arm slings, clavicle splints, external ankle braces, limb brace orthosis, rigid cervical-thoracic orthosis, knee cages, more...
E-Life International Co., Ltd | Address: 4 F-3, No. 366, Zhonghe Rd., Zhonghe City 235, Taiwan
www.e-lifebracing.com | Send Inquiry | Phone: +886-(2)-29231516
FDA Registration: 3005885000 Quality: DIN ISO 9001 standard Certified
Products: Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), External Brace Knee Joint (FDA Code: ITQ), Temporary Training Splint (FDA Code: IQM), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
E-Life International Co., Ltd is involved in the business of orthopedic braces and supports. We produce orthopedic products, such as functional knees, ankles, elbows, wrists, walkings, back & spine br more...
www.e-lifebracing.com | Send Inquiry | Phone: +886-(2)-29231516
FDA Registration: 3005885000 Quality: DIN ISO 9001 standard Certified
Products: Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), External Brace Knee Joint (FDA Code: ITQ), Temporary Training Splint (FDA Code: IQM), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
E-Life International Co., Ltd is involved in the business of orthopedic braces and supports. We produce orthopedic products, such as functional knees, ankles, elbows, wrists, walkings, back & spine br more...
Orthoservice Ag | Address: Rotzbergstr. 7, Stansstad 6362, Switzerland
www.orthoservice.com | Send Inquiry | Phone: +41-(41)-611-00-88
FDA Registration: 3004067876
Products: Cervical Collars, Orthopaedic Instruments, Cervical Thoracic Orthosis (FDA Code: IPT), Thoracic Orthosis, Brace (FDA Code: IPT), Hand Splint and Component (FDA Code: ILH), Knee Cage (FDA Code: ITM), ...
Orthoservice Ag produces and sells orthopedic products. We offer traction products for neck, back, shoulder, arm, hand, hip, knee, foot and toe. The neck products include Schanz cervical collars, Scha more...
www.orthoservice.com | Send Inquiry | Phone: +41-(41)-611-00-88
FDA Registration: 3004067876
Products: Cervical Collars, Orthopaedic Instruments, Cervical Thoracic Orthosis (FDA Code: IPT), Thoracic Orthosis, Brace (FDA Code: IPT), Hand Splint and Component (FDA Code: ILH), Knee Cage (FDA Code: ITM), ...
Orthoservice Ag produces and sells orthopedic products. We offer traction products for neck, back, shoulder, arm, hand, hip, knee, foot and toe. The neck products include Schanz cervical collars, Scha more...
DJ Orthopedics De Mexico, S.A. De C.V. | Address: Blvd., Delagacion La Presa, Otay Insurgentes 16695-1, Tijuana 22397, Mexico
Phone: +52-(664)-627-1300
FDA Registration: 9616086
Products: Catheter Accessories (FDA Code: KGZ), Cervicothoracic Lumbar Orthosis, Wheelchair Accessories (FDA Code: KNO), Wheelchair Accessories, Amputee Axle Kit, Chronic Catheter Accessories, Lumbar Orthosis, Brace (FDA Code: IQE), ...
DJ Orthopedics De Mexico, S.A. De C.V. offers orthopedic, prosthetic and surgical appliances & supplies. Our products include abdominal binders, ankle braces, abdominal supports, athletic tapes, cathe more...
Phone: +52-(664)-627-1300
FDA Registration: 9616086
Products: Catheter Accessories (FDA Code: KGZ), Cervicothoracic Lumbar Orthosis, Wheelchair Accessories (FDA Code: KNO), Wheelchair Accessories, Amputee Axle Kit, Chronic Catheter Accessories, Lumbar Orthosis, Brace (FDA Code: IQE), ...
DJ Orthopedics De Mexico, S.A. De C.V. offers orthopedic, prosthetic and surgical appliances & supplies. Our products include abdominal binders, ankle braces, abdominal supports, athletic tapes, cathe more...
Trulife Ltd. | Address: Unit 3 Cookstown Industrial, Estate, Tallaght, Dublin 24, Ireland
www.trulife.com | Send Inquiry | Phone: +353-(1)-4511755
FDA Registration: 9615374 Employee Count: ~20 Quality: ISO Certified
Products: Custom Walking Crutches, External Breast Prosthesis (FDA Code: KCZ), Support Gel Test (FDA Code: JZR), Skin Pressure Protector (FDA Code: FMP), Limb & Truncal Orthosis (FDA Code: MRI), Wheelchair Cushions (FDA Code: IMP), ...
Trulife Ltd. is engaged in the creation, development, manufacture and marketing of niche healthcare products. Our activities encompass orthopedics, prosthetics, breastcare and pressurecare products, a more...
www.trulife.com | Send Inquiry | Phone: +353-(1)-4511755
FDA Registration: 9615374 Employee Count: ~20 Quality: ISO Certified
Products: Custom Walking Crutches, External Breast Prosthesis (FDA Code: KCZ), Support Gel Test (FDA Code: JZR), Skin Pressure Protector (FDA Code: FMP), Limb & Truncal Orthosis (FDA Code: MRI), Wheelchair Cushions (FDA Code: IMP), ...
Trulife Ltd. is engaged in the creation, development, manufacture and marketing of niche healthcare products. Our activities encompass orthopedics, prosthetics, breastcare and pressurecare products, a more...
General Surgical Co., (india) Pvt. Ltd. | Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India 
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
Chrisdon (HK) Trading Co., Ltd | Address: Unit 2001-2005, 9 Wing Hong Street, Cheung Sha Wan, Kowloon, Hongkong 100000, Hong Kong 
Phone: +852-(230)-71-933
Products: Lumbar Orthosis, Brace (FDA Code: IQE), Spectacle Frame (FDA Code: HQZ), Non Prescription Sunglasses (FDA Code: HQY), Limb Brace Orthosis (FDA Code: IQI), Lumbosacral Orthosis (FDA Code: IPY), Spectacle (Prescription) Lens For Reading Discomfort (FDA Code: NJH), ...
Chrisdon (HK) Trading Co., Ltd manufactures eyewear products. We provide spectacle frames, sunglasses and spectacle lens for people with reading discomfort. more...
Phone: +852-(230)-71-933
Products: Lumbar Orthosis, Brace (FDA Code: IQE), Spectacle Frame (FDA Code: HQZ), Non Prescription Sunglasses (FDA Code: HQY), Limb Brace Orthosis (FDA Code: IQI), Lumbosacral Orthosis (FDA Code: IPY), Spectacle (Prescription) Lens For Reading Discomfort (FDA Code: NJH), ...
Chrisdon (HK) Trading Co., Ltd manufactures eyewear products. We provide spectacle frames, sunglasses and spectacle lens for people with reading discomfort. more...
Allmay International Limited | Address: Room 1405-6, 14/f, Fu Lee Commercial Building, 14-20 Pilkem Street, Jordan, Kowloon, Hong Kong
www.allmayltd.com | Send Inquiry | Phone: +852-(0)-23170418
FDA Registration: 3007109661
Products: Cervical Collars, Adjustable Knee Brace, Arm Slings (FDA Code: ILI), Clavicle Braces, Cast Shoe (FDA Code: IPG), External Ankle Brace (FDA Code: ITW), ...
Allmay International Limited provides orthopedic products to customers. Our products include cervical collar, neoprene shoulder support, adjustable rigid collar, clavicle brace, shoulder immobilizer, more...
www.allmayltd.com | Send Inquiry | Phone: +852-(0)-23170418
FDA Registration: 3007109661
Products: Cervical Collars, Adjustable Knee Brace, Arm Slings (FDA Code: ILI), Clavicle Braces, Cast Shoe (FDA Code: IPG), External Ankle Brace (FDA Code: ITW), ...
Allmay International Limited provides orthopedic products to customers. Our products include cervical collar, neoprene shoulder support, adjustable rigid collar, clavicle brace, shoulder immobilizer, more...
Bort Medical | Address: 39 Ziegeleistrasse, Weinstadt-Benzach 71384, Germany 
www.bort.de | Phone: +49-(7151)-992000
FDA Registration: 1000649241
Products: Elastic Bandages (FDA Code: FQM), Lumbar Orthosis, Brace (FDA Code: IQE), Hand Splint and Component (FDA Code: ILH), Flotation Cushion (FDA Code: KIC), Knee Cage (FDA Code: ITM), Hernia Support (FDA Code: EXN), ...
Bort Medical deals with medical aids. We provide neck, arm, finger, thumb, body, knee, ankle, foot and home care/OTC products. Our Stabilo® orthopaedic cervical support is used for operations of t more...
www.bort.de | Phone: +49-(7151)-992000
FDA Registration: 1000649241
Products: Elastic Bandages (FDA Code: FQM), Lumbar Orthosis, Brace (FDA Code: IQE), Hand Splint and Component (FDA Code: ILH), Flotation Cushion (FDA Code: KIC), Knee Cage (FDA Code: ITM), Hernia Support (FDA Code: EXN), ...
Bort Medical deals with medical aids. We provide neck, arm, finger, thumb, body, knee, ankle, foot and home care/OTC products. Our Stabilo® orthopaedic cervical support is used for operations of t more...
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FDA Code / Regulation: ITM / 890.3475
A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
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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