The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Craniofacial Plate And Screw System.
| Device ID | K080331 |
| 510k Number | K080331 |
| Device Name: | SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Amnon Talmor |
| Correspondent | Amnon Talmor SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-06 |
| Decision Date | 2008-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98004503812S0 | K080331 | 000 |
| H980045038120 | K080331 | 000 |
| H98004503811S0 | K080331 | 000 |
| H980045038110 | K080331 | 000 |
| H98004503802S0 | K080331 | 000 |
| H980045038020 | K080331 | 000 |
| H98004503801S0 | K080331 | 000 |
| H980045038010 | K080331 | 000 |