ANATOMICA GLENOID COMPONENT
FDA 510(k) clearance K990136 · decided 1999-03-01
Clearance details
- K-number
- K990136
- Device name
- ANATOMICA GLENOID COMPONENT
- Applicant
- Sulzer Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-14
- Decision date
- 1999-03-01
- Days to decision
- 46 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 |
|---|---|---|
| zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoi recall (Z-0226-2013) | Zimmer, Inc. | 2012-11-06 |
| Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370. recall (Z-1194-2007) | Zimmer Inc. | 2007-08-23 |