AMATOMICAL SHOULDER WITH REMOVABLE HEAD
FDA 510(k) clearance K030259 · decided 2003-04-24
Clearance details
- K-number
- K030259
- Device name
- AMATOMICAL SHOULDER WITH REMOVABLE HEAD
- Applicant
- Centerplus Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-24
- Decision date
- 2003-04-24
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KWS
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Anatomical Shoulder" Humeral stem recall (Z-0223-2013) | Zimmer, Inc. | 2012-11-06 |
| Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Hume recall (Z-0227-2013) | Zimmer, Inc. | 2012-11-06 |
| Anatomical Shoulder" Ball taper for humeral stem recall (Z-0232-2013) | Zimmer, Inc. | 2012-11-06 |