Cleared Special

LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System

K200790 · L & K Biomed Co., Ltd. · Orthopedic

Oct 2020

Decision

216d

Days

Class 2

Risk

About This 510(k) Submission

K200790 is an FDA 510(k) clearance for the LnK Spinal Fixation System, 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 October 28, 2020, 216 days after receiving the submission on March 26, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K200790 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 2020
Decision Date	October 28, 2020
Days to Decision	216 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.