OCG — Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented Class III
FDA product code OCG covers "Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented", a Class III medical device regulated under 21 CFR 888.3410. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.
Classification Details
- Product Code
- OCG
- Device Class
- Class III
- Regulation Number
- 888.3410
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Call for PMAs to be filed by 1/3/05 per 69 FR 59134 on 10/4/04 - Intended to replace the articulating surfaces of the hip while preserving the femoral head and neck and indicated for osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis of the femoral head.