Cleared Traditional

AccelFix Lumbar Plate System

K192481 · L & K Biomed Co., Ltd. · Orthopedic
Jul 2020
Decision
322d
Days
Class 2
Risk

About This 510(k) Submission

K192481 is an FDA 510(k) clearance for the 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 28, 2020, 322 days after receiving the submission on September 10, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K192481 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2019
Decision Date July 28, 2020
Days to Decision 322 days
Submission Type Traditional
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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