CONDUIT ZERO-P VA Secured Spacer System— 510(k) K252982

Name: FDA 510(k) clearance K252982
Creator: U.S. Food and Drug Administration
Published: 2026-06-18

Substantially Equivalent

Avalign 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.

Clearance details

Applicant: Avalign Technologies, Inc.
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-09-17
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Wayne, IN, US

Download summary PDF View on FDA.gov ↗

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K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K260036 — NeckTune 3D SA Cervical Cage2026-06-15

More clearances from Avalign Technologies, Inc.

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K250072 — CONDUIT SYNFIX Evolution Secured Spacer System2025-07-10
K193066 — Steripack cases and Tray Systems2020-08-06

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.