VariLift®-C Interbody Fusion System— 510(k) K231076

Substantially Equivalent

Wenzel Spine, Inc.

FDA 510(k) clearance K231076 for VariLift®-C Interbody Fusion System, Substantially Equivalent on 2023-09-27. Applicant: Wenzel Spine, Inc..

Clearance details

Applicant: Wenzel Spine, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2023-04-14
Decision date: 2023-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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.