OPTIMUS CMF SYSTEM
K-Number: K160363 · 2016-10-20
ApplicantOsteonic Co., Ltd.
Decision Date2016-10-20
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OPTIMUS CMF SYSTEM is a medical device manufactured by Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2016-10-20 under approval number K160363. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OPTIMUS CMF SYSTEM?
OPTIMUS CMF SYSTEM is a medical device that received FDA 510(k) clearance on 2016-10-20. It is manufactured by Osteonic Co., Ltd.. The 510(k) number is K160363.
When was OPTIMUS CMF SYSTEM approved by the FDA?
OPTIMUS CMF SYSTEM received FDA 510(k) clearance on 2016-10-20, under approval number K160363.
What company makes OPTIMUS CMF SYSTEM?
OPTIMUS CMF SYSTEM is manufactured by Osteonic Co., Ltd..
What is the FDA product code for OPTIMUS CMF SYSTEM?
The FDA product code for OPTIMUS CMF SYSTEM is JEY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.