SCHURMAN/CARTER HIP PROSTHESIS POROUS COATED
FDA 510(k) clearance K861450 · decided 1986-08-07
Clearance details
- K-number
- K861450
- Device name
- SCHURMAN/CARTER HIP PROSTHESIS POROUS COATED
- Applicant
- Kirschner Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-18
- Decision date
- 1986-08-07
- Days to decision
- 111 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Timonium, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.