The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthes Synpor Hd Porous Polyethylene Threr Dimensional Implants.
| Device ID | K111323 |
| 510k Number | K111323 |
| Device Name: | SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Alan T Haley |
| Correspondent | Alan T Haley SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | KKY |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-11 |
| Decision Date | 2011-11-16 |
| Summary: | summary |