Cleared Special

LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System

K200789 · L & K Biomed Co., Ltd. · Orthopedic

Dec 2020

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K200789 is an FDA 510(k) clearance for the LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal 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 4, 2020, 253 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	K200789 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 2020
Decision Date	December 04, 2020
Days to Decision	253 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.