The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Synthecel Dura Repair.
| Device ID | K212943 |
| 510k Number | K212943 |
| Device Name: | SyntheCel Dura Repair |
| Classification | Dura Substitute |
| Applicant | Synthes (USA) Products, LLC 1230 Wilson Dr. West Chester, PA 19380 |
| Contact | Doug Steinberger |
| Correspondent | Doug Steinberger Synthes (USA) Products, LLC 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 | 2021-09-15 |
| Decision Date | 2022-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587076669 | K212943 | 000 |