Data / Medical devices / United States / Zsfab Inc
Zsfab Inc: FDA-registered device maker in Waltham, MA, United States, 6 510(k) clearances
Zsfab Inc is registered with the FDA (registration 3022943642) in Waltham, MA, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 31, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3022943642
- Address
- 96 Clematis Ave STE 2F, Waltham, MA, United States, 02453
- Owner or operator
- ZSFab Inc (10084929)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 28, 2022
- Registered through
- 2027
- Brand names listed
- Orthopedic Manual Instrument, ZSAlign Cervical Interbody System, ZSFab Cervical Interbody System, ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System, ZSFab Lumbar Interbody System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2026 | K261451 | ZSAlign Cervical Interbody System | OVE | Substantially Equivalent | ZSFab, Inc. | accessdata.fda.gov |
| November 25, 2025 | K252610 | ZSFab Lumbar Interbody System | MAX | Substantially Equivalent | Zsfab, Inc. | accessdata.fda.gov |
| November 7, 2024 | K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | ODP | Substantially Equivalent | Zsfab | accessdata.fda.gov |
| August 18, 2023 | K232150 | ZSFab Cervical Interbody System | ODP | Substantially Equivalent | Zsfab, Inc. | accessdata.fda.gov |
| October 14, 2022 | K221858 | ZSFab Lumbar Interbody System | MAX | Substantially Equivalent | Zsfab, Inc. | accessdata.fda.gov |
| January 7, 2021 | K202488 | ZSFab Cervical Interbody System | ODP | Substantially Equivalent | Zsfab, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Orthopedic Manual Surgical Instrument
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.