K152463 is an FDA 510(k) clearance for the SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant, a Prosthesis, Chin, Internal (Class II — Special Controls, product code FWP), submitted by Poriferous, LLC (Newnan, US). The FDA issued a Cleared decision on January 20, 2016, 145 days after receiving the submission on August 28, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K152463 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 28, 2015 |
| Decision Date | January 20, 2016 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FWP — Prosthesis, Chin, Internal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3550 |