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

Name: FDA 510(k) clearance K262595
Creator: U.S. Food and Drug Administration
Published: 2026-08-26

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.

Clearance details

Applicant: Wenzel Spine, Inc.
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-07-27
Decision date: 2026-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

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K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08
K260840 — BluEX Cervical Expandable Cage System2026-05-16

More clearances from Wenzel Spine, Inc.

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K250247 — panaSIa SI Fusion System2025-07-09
K231076 — VariLift®-C Interbody Fusion System2023-09-27
K231807 — primaLOK SP Interspinous Fusion System2023-08-15
K180822 — VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System2019-01-28
K151900 — VariLift-L Interbody Fusion Device2015-12-11

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.