The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Patient Specific Cranial/craniofacial Implant.
| Device ID | K053199 |
| 510k Number | K053199 |
| Device Name: | SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Lisa Boyle |
| Correspondent | Lisa Boyle SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-16 |
| Decision Date | 2005-12-14 |
| Summary: | summary |