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.
Clearance details
- Applicant
- Life Spine, Inc.
- Product code
- 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.