K043250 is an FDA 510(k) clearance for the STRYKER PATIENT SPECIFIC POLYMER IMPLANT. This device is classified as a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (Class II - Special Controls, product code KKY).
Submitted by Stryker Leibinger (Kalamazoo, US). The FDA issued a Cleared decision on April 15, 2005, 143 days after receiving the submission on November 23, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3500.
| 510(k) Number | K043250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2004 |
| Decision Date | April 15, 2005 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3500 |