SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
FDA 510(k) clearance K083694 · decided 2009-03-06
Clearance details
- K-number
- K083694
- Device name
- SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2008-12-12
- Decision date
- 2009-03-06
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- HRS
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, recall (Z-2057-2013) | Synthes (USA) Products LLC | 2013-08-26 |
| Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended recall (Z-2087-2013) | Synthes USA HQ, Inc. | 2013-08-26 |
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 |