VersaLift Expandable System— 510(k) K260837
Substantially EquivalentLife Spine, Inc.
FDA 510(k) clearance K260837 for VersaLift Expandable System, Substantially Equivalent on 2026-05-12. Applicant: Life Spine, Inc.. Device class: 2.
Summary
Life Spine's VersaLift Expandable System is filed under MAX, lumbar intervertebral fusion devices with bone graft.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Life Spine filed from Huntley, Illinois. The decision came 60 calendar days after receipt (March 13 to May 12, 2026).
Clearance details
- Applicant
- Life Spine, Inc.
- Product code
- Product code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huntley, IL, US
Recent devices under product code MAX
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view all- K260571 — SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
- K254274 — ARx® SAI Implant System
- K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System
- K251502 — TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
- K250373 — ProLift Expandable Spacer System
Adverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . 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.