OMKNEE SYSTEM, POROUS COATED
FDA 510(k) clearance K854943 · decided 1986-02-20
Clearance details
- K-number
- K854943
- Device name
- OMKNEE SYSTEM, POROUS COATED
- Applicant
- Orthomet, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1985-12-10
- Decision date
- 1986-02-20
- Days to decision
- 72 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.