CONDUIT ZERO-P VA Secured Spacer System— 510(k) K252982
Substantially EquivalentAvalign Technologies, Inc.
FDA 510(k) clearance K252982 for CONDUIT ZERO-P VA Secured Spacer System, Substantially Equivalent on 2026-06-18. Applicant: Avalign Technologies, Inc.. Device class: 2.
Summary
Avalign Technologies' CONDUIT ZERO-P VA Secured Spacer System is filed under OVE, cervical intervertebral fusion devices with integrated fixation. The record doesn't expand "VA" or list spacer sizes.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Avalign filed from Fort Wayne, Indiana. The decision came 274 calendar days after FDA received it (September 17, 2025 to June 18, 2026).
Clearance details
- Applicant
- Avalign Technologies, Inc.
- Product code
- Product code OVE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Wayne, IN, US
Recent devices under product code OVE
view allMore clearances from Avalign Technologies, Inc.
view allAdverse events under product code OVE
product code OVE- Injury
- 293
- Malfunction
- 710
- Total
- 1,003
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.