KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
FDA 510(k) clearance K882241 · decided 1988-06-29
Clearance details
- K-number
- K882241
- Device name
- KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
- Applicant
- Kirschner Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-05-27
- Decision date
- 1988-06-29
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- HRY
- Device class
- 2
- Regulation number
- 888.3530
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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.