K183472 is an FDA 510(k) clearance for the DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on March 13, 2019, 89 days after receiving the submission on December 14, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K183472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2018 |
| Decision Date | March 13, 2019 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |