K161052 is an FDA 510(k) clearance for the OsteoFab Patient Specific Facial Device. This device is classified as a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (Class II - Special Controls, product code KKY).
Submitted by Oxford Performance Materials, Inc. (South Windsor, US). The FDA issued a Cleared decision on July 20, 2016, 97 days after receiving the submission on April 14, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3500.
| 510(k) Number | K161052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2016 |
| Decision Date | July 20, 2016 |
| Days to Decision | 97 days |
| Submission Type | Special |
| 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 |