Cleared Traditional

AccelFix Lumbar Interbody Fusion Cage System

K190708 · L & K Biomed Co., Ltd. · Orthopedic

Sep 2019

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K190708 is an FDA 510(k) clearance for the AccelFix Lumbar Interbody Fusion Cage System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on September 16, 2019, 181 days after receiving the submission on March 19, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K190708 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 2019
Decision Date	September 16, 2019
Days to Decision	181 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.