Cleared Traditional

FIX-C 3D Ti ACIF System

K243915 · Jeil Medical Corporation · Orthopedic

Feb 2025

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K243915 is an FDA 510(k) clearance for the FIX-C 3D Ti ACIF System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on February 18, 2025, 60 days after receiving the submission on December 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K243915 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2024
Decision Date	February 18, 2025
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, 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.