FDA 510(k) clearance · back to tracker

VariLift-C Cervical Interbody Fusion System

Wenzel Spine, Inc. cleared K262595 on 2026-08-26, decision: substantially equivalent

K-number

K262595

Sponsor

Wenzel Spine, Inc.

Device

VariLift-C Cervical Interbody Fusion System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-08-26

Product code

ODP

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3080

Official FDA record

Open K262595on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.