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FDA 510(k)

ReBOSSIS85

K-Number: K170620 · 2017-06-23

Decision Date2017-06-23
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ReBOSSIS85 is a medical device manufactured by Orthorebirth Co., Ltd.. It received FDA 510(k) clearance on 2017-06-23 under approval number K170620. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReBOSSIS85?

ReBOSSIS85 is a medical device that received FDA 510(k) clearance on 2017-06-23. It is manufactured by Orthorebirth Co., Ltd.. The 510(k) number is K170620.

When was ReBOSSIS85 approved by the FDA?

ReBOSSIS85 received FDA 510(k) clearance on 2017-06-23, under approval number K170620.

What company makes ReBOSSIS85?

ReBOSSIS85 is manufactured by Orthorebirth Co., Ltd..

What is the FDA product code for ReBOSSIS85?

The FDA product code for ReBOSSIS85 is MQV.

Other Devices by Orthorebirth Co., Ltd.

Related Devices (Code: MQV)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.