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FDA 510(k)

ReBOSSIS

K-Number: K240453 · 2024-03-04

ApplicantOrthorebirth Co., Ltd.
Decision Date2024-03-04
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ReBOSSIS 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 2024-03-04 under 510(k) 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. The listed applicant is Orthorebirth Co., Ltd.. The 510(k) number is K240453.

When did ReBOSSIS receive FDA 510(k) clearance?

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

Who is the listed applicant for ReBOSSIS?

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 ReBOSSIS?

The FDA product code for ReBOSSIS 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.

K172573ReBOSSIS85K170620ReBOSSIS85

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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

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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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