MODIFIED DISTAL RADIUS PLATING SYSTEM
FDA 510(k) clearance K133939 · decided 2014-04-01
Clearance details
- K-number
- K133939
- Device name
- MODIFIED DISTAL RADIUS PLATING SYSTEM
- Applicant
- Biomet
- Decision
- Substantially Equivalent
- Date received
- 2013-12-23
- Decision date
- 2014-04-01
- Days to decision
- 99 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 |
|---|---|---|
| Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, sc recall (Z-1082-2016) | Biomet, Inc. | 2016-03-08 |