2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
FDA 510(k) clearance K102694 · decided 2010-12-09
Clearance details
- K-number
- K102694
- Device name
- 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2010-09-20
- Decision date
- 2010-12-09
- Days to decision
- 80 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
+ Add to Predicate Builder ◉ Watch Synthes (Usa)
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4 recall (Z-2389-2016) | Synthes (USA) Products LLC | 2016-08-11 |
| Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02 recall (Z-0956-2013) | Synthes USA HQ, Inc. | 2013-03-15 |
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 |