VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System— 510(k) K180822

Substantially Equivalent

Wenzel Spine, Inc.

FDA 510(k) clearance K180822 for VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System, Substantially Equivalent on 2019-01-28. Applicant: Wenzel Spine, Inc..

Clearance details

Applicant: Wenzel Spine, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2018-03-30
Decision date: 2019-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.