Cleared Special

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

K231636 · L & K Biomed Co., Ltd. · Orthopedic

Jun 2023

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K231636 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 June 27, 2023, 22 days after receiving the submission on June 5, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K231636 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 2023
Decision Date	June 27, 2023
Days to Decision	22 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.