M.C.R. KNEE PROSTHESIS (SERIES 3000)
FDA 510(k) clearance K860654 · decided 1986-03-14
Clearance details
- K-number
- K860654
- Device name
- M.C.R. KNEE PROSTHESIS (SERIES 3000)
- Applicant
- Osteonics Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1986-02-21
- Decision date
- 1986-03-14
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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.