STRYKER PATIENT SPECIFIC POLYMER IMPLANT
FDA 510(k) clearance K103010 · decided 2010-10-26
Clearance details
- K-number
- K103010
- Device name
- STRYKER PATIENT SPECIFIC POLYMER IMPLANT
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2010-10-12
- Decision date
- 2010-10-26
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- KKY
- Device class
- 2
- Regulation number
- 878.3500
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Hos recall (Z-0975-2014) | Stryker Howmedica Osteonics Corp. | 2014-02-12 |