TRABECULAR METAL ACETABULAR AUGMENTS
FDA 510(k) clearance K061067 · decided 2006-05-25
Clearance details
- K-number
- K061067
- Device name
- TRABECULAR METAL ACETABULAR AUGMENTS
- Applicant
- Zimmer Trabecular
- Decision
- Substantially Equivalent
- Date received
- 2006-04-17
- Decision date
- 2006-05-25
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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