APEX REVISION KNEE SYSTEMS
FDA 510(k) clearance K112891 · decided 2012-02-29
Clearance details
- K-number
- K112891
- Device name
- APEX REVISION KNEE SYSTEMS
- Applicant
- Omni Life Science, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-09-30
- Decision date
- 2012-02-29
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- East Taunton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-5013 recall (Z-2069-2025) | CORIN MEDICAL, LTD. | 2025-07-02 |