Cleared Traditional

TruLift? Lateral Expandable Spacer & Lateral Buttress Plate System

K251502 · Life Spine, Inc. · Orthopedic

Jul 2025

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K251502 is an FDA 510(k) clearance for the TruLift? Lateral Expandable Spacer & Lateral Buttress Plate System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on July 7, 2025, 53 days after receiving the submission on May 15, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K251502 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2025
Decision Date	July 07, 2025
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.