Product code
OCG: Prosthesis, hip, pelvifemoral resurfacing, metal/polymer, uncemented
FDA product code · Class III · Orthopedic
Key facts
| Product code | OCG |
|---|---|
| Device | Prosthesis, hip, pelvifemoral resurfacing, metal/polymer, uncemented |
| Device class | Class III |
| Regulation number | 888.3410 |
| Review panel | Orthopedic |
| Medical specialty | Orthopedic |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database