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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2016-10-20 under 510(k) 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. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K160363.

When did OPTIMUS CMF SYSTEM receive FDA 510(k) clearance?

OPTIMUS CMF SYSTEM received FDA 510(k) clearance on 2016-10-20, under 510(k) number K160363.

Who is the listed applicant for OPTIMUS CMF SYSTEM?

The FDA 510(k) record lists Osteonic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIMUS CMF SYSTEM?

The FDA product code for OPTIMUS CMF SYSTEM is JEY.

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Related Devices (Code: JEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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