The following data is part of a premarket notification filed by Zsfab Inc. with the FDA for Zsfab Cervical Interbody System.
| Device ID | K202488 |
| 510k Number | K202488 |
| Device Name: | ZSFab Cervical Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | ZSFab Inc. 705 Cambridge Street STE 1 Cambridge, MA 02141 |
| Contact | Kai Xu |
| Correspondent | Karen E. Warden BackRoads Consulting Inc. 12520 Heath Road Chesterland, OH 44026 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2021-01-07 |