Total clearances
7
2021-01-07 → 2026-07-31
Name variants in FDA filings: Zsfab / ZSFab, Inc. / Zsfab, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| ODP |
Intervertebral Fusion Device With Bone Graft, Cervical |
Class II |
Orthopedic |
4 |
2026-04-24 |
| MAX |
Intervertebral Fusion Device With Bone Graft, Lumbar |
Class II |
Orthopedic |
2 |
2025-11-25 |
| OVE |
Intervertebral Fusion Device With Integrated Fixation, Cervical |
Class II |
Orthopedic |
1 |
2026-07-31 |
Filings
All 510(k) clearances (7)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-07-31 |
K261451 |
ZSAlign Cervical Interbody System |
OVE |
Class II |
Orthopedic |
| 2026-04-24 |
K260549 |
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System |
ODP |
Class II |
Orthopedic |
| 2025-11-25 |
K252610 |
ZSFab Lumbar Interbody System |
MAX |
Class II |
Orthopedic |
| 2024-11-07 |
K242734 |
ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System |
ODP |
Class II |
Orthopedic |
| 2023-08-18 |
K232150 |
ZSFab Cervical Interbody System |
ODP |
Class II |
Orthopedic |
| 2022-10-14 |
K221858 |
ZSFab Lumbar Interbody System |
MAX |
Class II |
Orthopedic |
| 2021-01-07 |
K202488 |
ZSFab Cervical Interbody System |
ODP |
Class II |
Orthopedic |