The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthecel Dura Repair, Synthecel Dura Onlay.
| Device ID | K131792 |
| 510k Number | K131792 |
| Device Name: | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY |
| Classification | Dura Substitute |
| Applicant | SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Heather Guerin |
| Correspondent | Heather Guerin SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-18 |
| Decision Date | 2013-12-16 |
| Summary: | summary |