Cleared Special

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.

K223565 · L & K Biomed Co., Ltd. · Orthopedic

Dec 2022

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K223565 is an FDA 510(k) clearance for the LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, 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 December 23, 2022, 24 days after receiving the submission on November 29, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K223565 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2022
Decision Date	December 23, 2022
Days to Decision	24 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.