The following data is part of a premarket notification filed by Zs Fab Inc. with the FDA for Zsfab Lumbar Interbody System.
| Device ID | K221858 |
| 510k Number | K221858 |
| Device Name: | ZSFab Lumbar Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ZS Fab Inc. 96 Clematis Ave Suite 2F Waltham, MA 02453 |
| Contact | Xuewei Ma |
| Correspondent | Karen E Warden BackRoads Consulting Inc. PO Box 566 Chesterland, OH 44026 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-27 |
| Decision Date | 2022-10-14 |