Cleared Traditional

OPTIMUS CMF SYSTEM

K140037 · Osteonic Co., Ltd. · Dental
Jan 2015
Decision
378d
Days
Class 2
Risk

About This 510(k) Submission

K140037 is an FDA 510(k) clearance for the OPTIMUS CMF SYSTEM, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Osteonic Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on January 20, 2015, 378 days after receiving the submission on January 7, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K140037 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2014
Decision Date January 20, 2015
Days to Decision 378 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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