Post Surgical Pylon Suppliers
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.ti-med.com | Send Inquiry | Phone: +1-(310)-2121232
Products: Clamps, Foot Prosthesis, Ankle Prosthesis, Foot Prosthetics, Foot Arch Prosthesis, External Knee/Shank/Ankle/Foot Assembly (FDA Code: ISW), ...
Timed Inc. specializes in the manufacture of prosthetic components. Our prosthetic knee component provides pivot axis from the knee center for locking function. Our aluminum prosthetic components are more...
www.orthoinnovations.com | Send Inquiry | Phone: +1-(507)-536-6107, 877-536-6107
Products: Elbow Braces, Hinged knee Brace, Elbow Braces & Supports, Adjustable Knee Brace, Elastic Spiral Knee Brace, External Brace Knee Joint (FDA Code: ITQ), ...
Ortho Innovations, Inc. specializes in clinical orthotics and prosthetics. Our product focus is primarily targeted to meet the prescription demands of orthopedic and rehabilitative branches of medicin more...
A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
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.
