Cleared Traditional

FIX-C PEEK ACIF SA System

K251431 · Jeil Medical Corporation · Orthopedic

Jun 2025

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K251431 is an FDA 510(k) clearance for the FIX-C PEEK ACIF SA System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on June 27, 2025, 50 days after receiving the submission on May 8, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K251431 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2025
Decision Date	June 27, 2025
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.