Cleared Traditional

Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System

K253748 · Life Spine, Inc. · Orthopedic

Jan 2026

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K253748 is an FDA 510(k) clearance for the Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer 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 January 23, 2026, 59 days after receiving the submission on November 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K253748 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2025
Decision Date	January 23, 2026
Days to Decision	59 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.