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FDA 510(k)

ReBOSSIS85

K-Number: K172573 · 2017-12-15

ApplicantOrthorebirth Co., Ltd.
Decision Date2017-12-15
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ReBOSSIS85 is the device name listed in this FDA 510(k) record. The listed applicant is Orthorebirth Co., Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K172573. 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 2017-12-15. The listed applicant is Orthorebirth Co., Ltd.. The 510(k) number is K172573.

When did ReBOSSIS85 receive FDA 510(k) clearance?

ReBOSSIS85 received FDA 510(k) clearance on 2017-12-15, under 510(k) number K172573.

Who is the listed applicant for ReBOSSIS85?

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

What is the FDA product code for ReBOSSIS85?

The FDA product code for ReBOSSIS85 is MQV.

Other records listing Orthorebirth Co., Ltd. as applicant

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.

K240453ReBOSSISK170620ReBOSSIS85

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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.

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