TruLift Expandable System— 510(k) K261430
Substantially EquivalentLife Spine, Inc.
FDA 510(k) clearance K261430 for TruLift Expandable System, Substantially Equivalent on 2026-07-28. Applicant: Life Spine, Inc.. Device class: 2.
Summary
Life Spine's TruLift Expandable System is filed under MAX, lumbar intervertebral fusion devices with bone graft. The record doesn't give sizes or materials.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).
Life Spine filed from Huntley, Illinois. Review took 89 calendar days (April 30 to July 28, 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
view allMore clearances from Life Spine, Inc.
view all- K260571 — SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
- K260837 — VersaLift Expandable System
- 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
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.