DISTAL VOLAR RADIUS PLATING SYSTEMS
FDA 510(k) clearance K112345 · decided 2011-10-31
Clearance details
- K-number
- K112345
- Device name
- DISTAL VOLAR RADIUS PLATING SYSTEMS
- Applicant
- Medos International SARL
- Decision
- Substantially Equivalent
- Date received
- 2011-08-15
- Decision date
- 2011-10-31
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- LXT
- 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 |
|---|---|---|
| Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, sc recall (Z-1082-2016) | Biomet, Inc. | 2016-03-08 |
| LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopa recall (Z-1446-2015) | Biomet, Inc. | 2015-04-14 |