ORTHOMET LHMC FEMORAL STEM
FDA 510(k) clearance K931678 · decided 1994-10-14
Clearance details
- K-number
- K931678
- Device name
- ORTHOMET LHMC FEMORAL STEM
- Applicant
- Orthomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-04-06
- Decision date
- 1994-10-14
- Days to decision
- 556 days
- Clearance type
- Traditional
- Product code
- HMC
- Device class
- 2
- Regulation number
- 886.1510
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.