The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Vertebral Spacer.
| Device ID | K011037 |
| 510k Number | K011037 |
| Device Name: | VERTEBRAL SPACER |
| 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 | 2001-04-05 |
| Decision Date | 2002-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981088041100 | K011037 | 000 |
| H981088040430 | K011037 | 000 |
| H981088040420 | K011037 | 000 |
| H981088040410 | K011037 | 000 |
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