The following data is part of a premarket notification filed by Depuy Synthes Spine with the FDA for Synmesh System.
| Device ID | K183054 |
| 510k Number | K183054 |
| Device Name: | SYNMESH System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767 |
| Contact | Michelle Hughes |
| Correspondent | Michelle Hughes DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-02 |
| Decision Date | 2019-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034817910 | K183054 | 000 |