The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Vertebral Spacer Ti.
| Device ID | K020152 |
| 510k Number | K020152 |
| Device Name: | SYNTHES VERTEBRAL SPACER TI |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Jonathan Gilbert |
| Correspondent | Jonathan Gilbert SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-17 |
| Decision Date | 2002-04-16 |
| Summary: | summary |