The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Synmesh Spacer System.
| Device ID | K003275 |
| 510k Number | K003275 |
| Device Name: | SYNTHES SYNMESH SPACER SYSTEM |
| 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 | 2000-10-19 |
| Decision Date | 2001-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9814956240 | K003275 | 000 |
| H9814956020 | K003275 | 000 |
| H9814956010 | K003275 | 000 |
| H9814954100 | K003275 | 000 |
| 10705034817996 | K003275 | 000 |
| 10705034817989 | K003275 | 000 |
| 10705034817965 | K003275 | 000 |
| 10705034817958 | K003275 | 000 |
| 10705034817941 | K003275 | 000 |
| 10705034817934 | K003275 | 000 |
| H9814956030 | K003275 | 000 |
| H9814956040 | K003275 | 000 |
| H9814956230 | K003275 | 000 |
| H9814956220 | K003275 | 000 |
| H9814956210 | K003275 | 000 |
| H9814956150 | K003275 | 000 |
| H9814956140 | K003275 | 000 |
| H9814956130 | K003275 | 000 |
| H9814956120 | K003275 | 000 |
| H9814956110 | K003275 | 000 |
| H9814956050 | K003275 | 000 |
| 10705034817927 | K003275 | 000 |