510(k) clearance
ZSAlign Cervical Interbody System
- 510(k) number
- K263113
- Applicant
- ZSFab, Inc.
- Decision date
- Oct 2, 2026
- Date received
- Sep 4, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- OVE
- Device type
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device class
- Class II
- Regulation
- 21 CFR 888.3080
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Waltham, MA, US