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FDA 510(k)

Bi-Ostetic Bioactive Glass Foam

K-Number: K170917 · 2017-10-30

ApplicantBerkeley Advanced Biomaterials
Decision Date2017-10-30
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Bi-Ostetic Bioactive Glass Foam is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Advanced Biomaterials. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K170917. 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 Bi-Ostetic Bioactive Glass Foam?

Bi-Ostetic Bioactive Glass Foam is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Berkeley Advanced Biomaterials. The 510(k) number is K170917.

When did Bi-Ostetic Bioactive Glass Foam receive FDA 510(k) clearance?

Bi-Ostetic Bioactive Glass Foam received FDA 510(k) clearance on 2017-10-30, under 510(k) number K170917.

Who is the listed applicant for Bi-Ostetic Bioactive Glass Foam?

The FDA 510(k) record lists Berkeley Advanced Biomaterials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bi-Ostetic Bioactive Glass Foam?

The FDA product code for Bi-Ostetic Bioactive Glass Foam is MQV.

Related Devices (Code: MQV)

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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