TRABECULAR METAL KNEE SYSTEM AUGMENTS
FDA 510(k) clearance K040487 · decided 2004-12-21
Clearance details
- K-number
- K040487
- Device name
- TRABECULAR METAL KNEE SYSTEM AUGMENTS
- Applicant
- Implex Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-25
- Decision date
- 2004-12-21
- Days to decision
- 300 days
- Clearance type
- Traditional
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- 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 |
|---|---|---|
| NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, recall (Z-1325-2015) | Zimmer Trabecular Metal Technology, Inc. | 2015-03-26 |