Cleared Special

CastleLoc-P Anterior Cervical Plate System

K190425 · L & K Biomed Co., Ltd. · Orthopedic
Mar 2019
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K190425 is an FDA 510(k) clearance for the CastleLoc-P Anterior Cervical 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 March 21, 2019, 27 days after receiving the submission on February 22, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K190425 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2019
Decision Date March 21, 2019
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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