The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Vertebral Spacer Ti (curved And Narrow).
| Device ID | K024364 |
| 510k Number | K024364 |
| Device Name: | SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW) |
| 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 | 2002-12-31 |
| Decision Date | 2003-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9814951060 | K024364 | 000 |
| H9814899020 | K024364 | 000 |
| H9814899030 | K024364 | 000 |
| H9814899040 | K024364 | 000 |
| H9814899050 | K024364 | 000 |
| H9814899060 | K024364 | 000 |
| H9814951010 | K024364 | 000 |
| H9814951020 | K024364 | 000 |
| H9814951030 | K024364 | 000 |
| H9814951040 | K024364 | 000 |
| H9814951050 | K024364 | 000 |
| H9814899010 | K024364 | 000 |