METAL BACKED ACETABULAR COMPONENT
FDA 510(k) clearance K950542 · decided 1995-05-25
Clearance details
- K-number
- K950542
- Device name
- METAL BACKED ACETABULAR COMPONENT
- Applicant
- Encore Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-07
- Decision date
- 1995-05-25
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- JDL
- Device class
- 3
- Regulation number
- 888.3320
- 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 |
|---|---|---|
| Porous titanium flared rim acetabular shell with three clustered holes in even sizes from recall (Z-0799-06) | Encore Medical, Lp | 2006-04-27 |