INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
FDA 510(k) clearance K993259 · decided 2000-03-10
Clearance details
- K-number
- K993259
- Device name
- INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
- Applicant
- Sulzer Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-29
- Decision date
- 2000-03-10
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component recall (Z-1294-2023) | Zimmer, Inc. | 2023-03-29 |
| CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem co recall (Z-1132-2015) | Zimmer Gmbh | 2015-02-20 |
| CoCr Head, sterile, Rx recall (Z-0222-2013) | Zimmer, Inc. | 2012-11-06 |