The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Synthes Cervical Vertabrae Plates.
| Device ID | K792352 |
| 510k Number | K792352 |
| Device Name: | SYNTHES CERVICAL VERTABRAE PLATES |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DEPUY SYNTHES 325 Paramount Drive Raynham, MA 02767 |
| Contact | Unknown Unknown |
| Correspondent | Unknown Unknown DEPUY SYNTHES 325 PARAMOUNT DRIVE Raynham, MA 02767 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-19 |
| Decision Date | 1979-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981241590 | K792352 | 000 |
| H981241580 | K792352 | 000 |
| H981241570 | K792352 | 000 |
| H981241550 | K792352 | 000 |
| H981241540 | K792352 | 000 |
| H981241530 | K792352 | 000 |
| H981241520 | K792352 | 000 |
| H981241510 | K792352 | 000 |
| H981241500 | K792352 | 000 |