TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
FDA 510(k) clearance K040630 · decided 2004-09-30
Clearance details
- K-number
- K040630
- Device name
- TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
- Applicant
- Implex Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-10
- Decision date
- 2004-09-30
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. The objective o recall (Z-2439-2010) | Zimmer Inc. | 2010-09-20 |
| TRABECULAR METAL FEMORAL CONE AUGMENT - RIGHT, Part Number: 00-5450-012-32. The objective recall (Z-2440-2010) | Zimmer Inc. | 2010-09-20 |