The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Anterior Cervical Vertebrae Plate System.
| Device ID | K945700 |
| 510k Number | K945700 |
| Device Name: | SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Contact | Diane T Brown |
| Correspondent | Diane T Brown SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-16 |
| Decision Date | 1995-07-20 |