K261451
- 510(k) number
- K261451
- Device name
- ZSAlign Cervical Interbody System
- Applicant
- ZSFab, Inc. MA · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2026-07-31
- Date received
- 2026-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K261451.pdf
Official FDA record: K261451
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.