Cleared Special

OPTIMUS CMF SYSTEM

K160363 · Osteonic Co., Ltd. · Dental
Oct 2016
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K160363 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 October 20, 2016, 254 days after receiving the submission on February 9, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K160363 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2016
Decision Date October 20, 2016
Days to Decision 254 days
Submission Type Special
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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