4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
FDA 510(k) clearance K110354 · decided 2011-03-04
Clearance details
- K-number
- K110354
- Device name
- 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
- Applicant
- Synthes USA
- Decision
- Substantially Equivalent
- Date received
- 2011-02-07
- Decision date
- 2011-03-04
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- JDP
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
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| Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins (K162124) | DePuy Synthes | 2017-03-29 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Com recall (Z-1125-2014) | Synthes, Inc. | 2014-03-04 |
| Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD recall (Z-0401-2014) | Synthes USA HQ, Inc. | 2013-11-26 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |