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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08500351650005 | K202488 | 000 |
| 08500351650098 | K202488 | 000 |
| 08500351650081 | K202488 | 000 |
| 08500351650074 | K202488 | 000 |
| 08500351650067 | K202488 | 000 |
| 08500351650050 | K202488 | 000 |
| 08500351650043 | K202488 | 000 |
| 08500351650036 | K202488 | 000 |
| 08500351650029 | K202488 | 000 |
| 08500351650104 | K202488 | 000 |
| 08500351650111 | K202488 | 000 |
| 08500351650197 | K202488 | 000 |
| 08500351650180 | K202488 | 000 |
| 08500351650173 | K202488 | 000 |
| 08500351650166 | K202488 | 000 |
| 08500351650159 | K202488 | 000 |
| 08500351650142 | K202488 | 000 |
| 08500351650135 | K202488 | 000 |
| 08500351650128 | K202488 | 000 |
| 08500351650012 | K202488 | 000 |