The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Resorbable Cranial Clamp, (modified).
| Device ID | K031654 |
| 510k Number | K031654 |
| Device Name: | SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) |
| Classification | Cover, Burr Hole |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Bonnie Smith |
| Correspondent | Bonnie Smith SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-28 |
| Decision Date | 2003-08-08 |
| Summary: | summary |