K140437 is an FDA 510(k) clearance for the SU-POR SURGICAL IMPLANT, a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (Class II — Special Controls, product code KKY), submitted by Poriferous, LLC (Newnan, US). The FDA issued a Cleared decision on June 13, 2014, 112 days after receiving the submission on February 21, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3500.
| 510(k) Number | K140437 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 21, 2014 |
| Decision Date | June 13, 2014 |
| Days to Decision | 112 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 |