Cleared Special

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System

K231839 · L & K Biomed Co., Ltd. · Orthopedic
Jul 2023
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K231839 is an FDA 510(k) clearance for the CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on July 19, 2023, 27 days after receiving the submission on June 22, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K231839 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2023
Decision Date July 19, 2023
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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