DeviceClearance

VariLift-C Cervical Interbody Fusion System— 510(k) K262595

Substantially Equivalent

Wenzel Spine, Inc.

FDA 510(k) clearance K262595 for VariLift-C Cervical Interbody Fusion System, Substantially Equivalent on 2026-08-26. Applicant: Wenzel Spine, Inc.. Device class: 2.

Summary

Wenzel Spine's VariLift-C Cervical Interbody Fusion System is filed under product code ODP, cervical intervertebral fusion devices with bone graft. No model numbers are listed.

Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).

Wenzel Spine filed from Austin, Texas. FDA found it substantially equivalent 30 calendar days after receipt (July 27 to August 26, 2026).

Clearance details

Applicant
Wenzel Spine, Inc.
Product code
Product code ODP
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Austin, TX, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code ODP

product code ODP
Injury
310
Total
310

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.