Cleared Special

LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System

K230245 · L & K Biomed Co., Ltd. · Orthopedic

Feb 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K230245 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 February 28, 2023, 29 days after receiving the submission on January 30, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K230245 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2023
Decision Date	February 28, 2023
Days to Decision	29 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.