Cleared Traditional

ProLift Expandable Spacer System

K250373 · Life Spine, Inc. · Orthopedic

Apr 2025

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K250373 is an FDA 510(k) clearance for the ProLift 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 April 9, 2025, 58 days after receiving the submission on February 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K250373 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 2025
Decision Date	April 09, 2025
Days to Decision	58 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.