K211514 is an FDA 510(k) clearance for the Longeviti PorousFit implant. This device is classified as a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (Class II - Special Controls, product code KKY).
Submitted by Longeviti Neuro Solutions, LLC (Hunt Valley, US). The FDA issued a Cleared decision on July 15, 2021, 59 days after receiving the submission on May 17, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3500.
| 510(k) Number | K211514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2021 |
| Decision Date | July 15, 2021 |
| Days to Decision | 59 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 |