Cleared Traditional

FIX-L PEEK PLIF and T-PLIF System

K243973 · Jeil Medical Corporation · Orthopedic

Jun 2025

Decision

171d

Days

Class 2

Risk

About This 510(k) Submission

K243973 is an FDA 510(k) clearance for the FIX-L PEEK PLIF and T-PLIF System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on June 12, 2025, 171 days after receiving the submission on December 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K243973 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2024
Decision Date	June 12, 2025
Days to Decision	171 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.