The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (u.s.a.) Anterior Cervical Vertebrae Plate.
| Device ID | K926453 |
| 510k Number | K926453 |
| Device Name: | SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Diane C Tierman |
| Correspondent | Diane C Tierman SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-24 |
| Decision Date | 1993-10-12 |