WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS
FDA premarket approval P880076/S001 · decided 1991-06-17
Approval details
- PMA number
- P880076
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS
- Generic name
- PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
- Applicant
- Dow Corning Wright
- Date received
- 1990-10-17
- Decision date
- 1991-06-17
- Days to decision
- 243 days
- Decision code
- APPR
- Product code
- LPH
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Arlington, TN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT (K932210) | Dow Corning Wright | 1994-09-07 |
| ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT (K932911) | Dow Corning Wright | 1994-06-30 |
| LACEY ALL POLYETHYLENE TIBIAL COMPONENT (K934354) | Dow Corning Wright | 1994-06-03 |
| SLT FEMORAL HEAD (K932222) | Dow Corning Wright | 1994-05-27 |
| ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT (K932858) | Dow Corning Wright | 1994-02-16 |
| ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE (K930228) | Dow Corning Wright | 1993-11-30 |
| LACEY REVISION FEMORAL COMPONENT (K925900) | Dow Corning Wright | 1993-08-24 |
| ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP (K930189) | Dow Corning Wright | 1993-08-06 |