The following data is part of a premarket notification filed by Howmedica Osteonics Corp. Dba Stryker Orthopeadics with the FDA for Stryker (r) Patient Specific Polymer Implant.
| Device ID | K111065 |
| 510k Number | K111065 |
| Device Name: | STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Caludia Wiesemann |
| Correspondent | Caludia Wiesemann HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPEADICS 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-07-14 |
| Summary: | summary |