Cleared Traditional

ProLift Wedge Expandable Spacer System

K242826 · Life Spine, Inc. · Orthopedic

Oct 2024

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K242826 is an FDA 510(k) clearance for the ProLift Wedge 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 October 8, 2024, 20 days after receiving the submission on September 18, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K242826 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2024
Decision Date	October 08, 2024
Days to Decision	20 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.