The following data is part of a premarket notification filed by Synthes with the FDA for Synthecel Dura Replacement Devices.
| Device ID | K113071 |
| 510k Number | K113071 |
| Device Name: | SYNTHECEL DURA REPLACEMENT DEVICES |
| Classification | Dura Substitute |
| Applicant | SYNTHES 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Andrea M Tasker |
| Correspondent | Andrea M Tasker SYNTHES 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 | 2011-10-17 |
| Decision Date | 2012-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980SC40012001S0 | K113071 | 000 |
| H980SC40005601S0 | K113071 | 000 |
| H980SC40002501S0 | K113071 | 000 |
| H980SC40001901S0 | K113071 | 000 |
| H980SC40000601S0 | K113071 | 000 |