The following data is part of a premarket notification filed by Synthes with the FDA for Synthes Synex Spacer System.
| Device ID | K003836 |
| 510k Number | K003836 |
| Device Name: | SYNTHES SYNEX SPACER SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SYNTHES 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Jonathan Gilbert |
| Correspondent | Jonathan Gilbert SYNTHES 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 | 2000-12-12 |
| Decision Date | 2001-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9814953270 | K003836 | 000 |
| H981048072370 | K003836 | 000 |
| H981048072330 | K003836 | 000 |
| H981048072310 | K003836 | 000 |
| H981048072260 | K003836 | 000 |
| H981048072230 | K003836 | 000 |
| H981048071360 | K003836 | 000 |
| H981048071280 | K003836 | 000 |
| H981048071230 | K003836 | 000 |
| H981048072450 | K003836 | 000 |
| H9814953150 | K003836 | 000 |
| H9814953250 | K003836 | 000 |
| H9814953230 | K003836 | 000 |
| H9814953210 | K003836 | 000 |
| H9814953200 | K003836 | 000 |
| H9814953190 | K003836 | 000 |
| H9814953180 | K003836 | 000 |
| H9814953170 | K003836 | 000 |
| H9814953160 | K003836 | 000 |
| H981048071200 | K003836 | 000 |