Cleared Traditional

AccelFix Spinal Fixation System

K182544 · L & K Biomed Co., Ltd. · Orthopedic

May 2019

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K182544 is an FDA 510(k) clearance for the AccelFix Spinal Fixation System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on May 28, 2019, 253 days after receiving the submission on September 17, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K182544 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2018
Decision Date	May 28, 2019
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.