The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Depuy Synthes Porous Polyethylene Implants And Titanium Wires Portfolio – Mr Conditional.
| Device ID | K183472 |
| 510k Number | K183472 |
| Device Name: | DePuy Synthes Porous Polyethylene Implants And Titanium Wires Portfolio – MR Conditional |
| Classification | Mesh, Surgical |
| Applicant | Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Fredy Varela |
| Correspondent | Fredy Varela Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-14 |
| Decision Date | 2019-03-13 |