The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Anterior Cslp System.
| Device ID | K030866 |
| 510k Number | K030866 |
| Device Name: | SYNTHES ANTERIOR CSLP SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES (USA) 1380 ENTERPRISE DR. West Chester, PA 19380 |
| Contact | Jonathan Gilbert |
| Correspondent | Jonathan Gilbert SYNTHES (USA) 1380 ENTERPRISE DR. West Chester, PA 19380 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-19 |
| Decision Date | 2003-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9814501490 | K030866 | 000 |
| H9814501480 | K030866 | 000 |
| H9814501470 | K030866 | 000 |