The following data is part of a premarket notification filed by Synthes with the FDA for Synthes Matrixneuro Cranial Plating System.
| Device ID | K123723 |
| 510k Number | K123723 |
| Device Name: | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | SYNTHES 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Alan T Haley |
| Correspondent | Alan T Haley SYNTHES 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-04 |
| Decision Date | 2013-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98004503150S0 | K123723 | 000 |
| H98004503149S0 | K123723 | 000 |
| H98004503147S0 | K123723 | 000 |
| H98004503146S0 | K123723 | 000 |
| H98004503145S0 | K123723 | 000 |