ANATOMICAL SHOULDER INVERSE/REVERSE
FDA 510(k) clearance K053274 · decided 2006-01-25
Clearance details
- K-number
- K053274
- Device name
- ANATOMICAL SHOULDER INVERSE/REVERSE
- Applicant
- Zimmer GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-11-23
- Decision date
- 2006-01-25
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- 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 |
|---|---|---|
| Anatomical Shoulder" Inverse Humeral Cup recall (Z-0229-2013) | Zimmer, Inc. | 2012-11-06 |
| Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx recall (Z-0230-2013) | Zimmer, Inc. | 2012-11-06 |
| Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx recall (Z-0231-2013) | Zimmer, Inc. | 2012-11-06 |