K252982
- 510(k) number
- K252982
- Device name
- CONDUIT ZERO-P VA Secured Spacer System
- Applicant
- Avalign Technologies, Inc. IN · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2026-06-18
- Date received
- 2025-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K252982.pdf
Official FDA record: K252982
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.