TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
FDA 510(k) clearance K094017 · decided 2010-03-05
Clearance details
- K-number
- K094017
- Device name
- TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
- Applicant
- Omni Life Science, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-29
- Decision date
- 2010-03-05
- Days to decision
- 66 days
- Clearance type
- Special
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The A recall (Z-2370-2012) | Omni Life Science | 2012-09-13 |
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The A recall (Z-2371-2012) | Omni Life Science | 2012-09-13 |
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The A recall (Z-2372-2012) | Omni Life Science | 2012-09-13 |
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The A recall (Z-2373-2012) | Omni Life Science | 2012-09-13 |
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The A recall (Z-2374-2012) | Omni Life Science | 2012-09-13 |
| Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The A recall (Z-2375-2012) | Omni Life Science | 2012-09-13 |