TRABECULAR METAL TIBIAL CONE AUGMENTS
FDA 510(k) clearance K102896 · decided 2010-12-13
Clearance details
- K-number
- K102896
- Device name
- TRABECULAR METAL TIBIAL CONE AUGMENTS
- Applicant
- Zimmer Trabecular Metal Technology
- Decision
- Substantially Equivalent
- Date received
- 2010-09-30
- Decision date
- 2010-12-13
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.