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FDA 510(k)

ReBOSSIS

K-Number: K240453 · 2024-03-04

Decision Date2024-03-04
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ReBOSSIS is a medical device manufactured by Orthorebirth Co., Ltd.. It received FDA 510(k) clearance on 2024-03-04 under approval number K240453. 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 ReBOSSIS?

ReBOSSIS is a medical device that received FDA 510(k) clearance on 2024-03-04. It is manufactured by Orthorebirth Co., Ltd.. The 510(k) number is K240453.

When was ReBOSSIS approved by the FDA?

ReBOSSIS received FDA 510(k) clearance on 2024-03-04, under approval number K240453.

What company makes ReBOSSIS?

ReBOSSIS is manufactured by Orthorebirth Co., Ltd..

What is the FDA product code for ReBOSSIS?

The FDA product code for ReBOSSIS 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.