Cleared Special

OpenLoc-L Spinal Fixation System

K183168 · L & K Biomed Co., Ltd. · Orthopedic

Dec 2018

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K183168 is an FDA 510(k) clearance for the OpenLoc-L 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 December 11, 2018, 25 days after receiving the submission on November 16, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K183168 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2018
Decision Date	December 11, 2018
Days to Decision	25 days
Submission Type	Special
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.