NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
FDA 510(k) clearance K061211 · decided 2006-06-14
Clearance details
- K-number
- K061211
- Device name
- NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
- Applicant
- Zimmer GmbH
- Decision
- Substantially Equivalent
- Date received
- 2006-05-01
- Decision date
- 2006-06-14
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NCB cancellous screw recall (Z-0243-2013) | Zimmer, Inc. | 2012-11-06 |
| NCB screw 4.0 self-tapping recall (Z-0244-2013) | Zimmer, Inc. | 2012-11-06 |
| NCB-PT lateral proximal 3 hole tibial plate recall (Z-0245-2013) | Zimmer, Inc. | 2012-11-06 |