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

Clearance details

Applicant

Wenzel Spine, Inc.

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2018-03-30

Decision date

2019-01-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Austin, TX, US

• K261049 — SCALA® TL2026-08-20
• K261430 — TruLift Expandable System2026-07-28
• K253011 — Catalyft PL Expandable Interbody System2026-07-17
• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
• K250247 — panaSIa SI Fusion System2025-07-09
• K231076 — VariLift®-C Interbody Fusion System2023-09-27
• K231807 — primaLOK SP Interspinous Fusion System2023-08-15
• K151900 — VariLift-L Interbody Fusion Device2015-12-11

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 →