DEPUY GLOBAL UNITE SHOULDER SYSTEM
FDA 510(k) clearance K133834 · decided 2014-04-03
Clearance details
- K-number
- K133834
- Device name
- DEPUY GLOBAL UNITE SHOULDER SYSTEM
- Applicant
- Depuy(Ireland)
- Decision
- Substantially Equivalent
- Date received
- 2013-12-17
- Decision date
- 2014-04-03
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- KWS
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Co. Cork, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total sho recall (Z-1012-2018) | DePuy Orthopaedics, Inc. | 2018-02-27 |