OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE
FDA 510(k) clearance K864372 · decided 1986-11-25
Clearance details
- K-number
- K864372
- Device name
- OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE
- Applicant
- Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-05
- Decision date
- 1986-11-25
- Days to decision
- 20 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.