K111065 is an FDA 510(k) clearance for the STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT. This device is classified as a Plate, Cranioplasty, Preformed, Alterable (Class II - Special Controls, product code GWO).
Submitted by Howmedica Osteonics Corp. Dba Stryker Orthopeadics (Mahwah, US). The FDA issued a Cleared decision on July 14, 2011, 87 days after receiving the submission on April 18, 2011.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 882.5320.
| 510(k) Number | K111065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2011 |
| Decision Date | July 14, 2011 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GWO — Plate, Cranioplasty, Preformed, Alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5320 |