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FDA 510(k)

BonAlive Granules

K-Number: K191274 · 2019-08-07

ApplicantBonalive Biomaterials, Ltd.
Decision Date2019-08-07
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BonAlive Granules is the device name listed in this FDA 510(k) record. The listed applicant is Bonalive Biomaterials, Ltd.. It received FDA 510(k) clearance on 2019-08-07 under 510(k) number K191274. 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 BonAlive Granules?

BonAlive Granules is a medical device that received FDA 510(k) clearance on 2019-08-07. The listed applicant is Bonalive Biomaterials, Ltd.. The 510(k) number is K191274.

When did BonAlive Granules receive FDA 510(k) clearance?

BonAlive Granules received FDA 510(k) clearance on 2019-08-07, under 510(k) number K191274.

Who is the listed applicant for BonAlive Granules?

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

What is the FDA product code for BonAlive Granules?

The FDA product code for BonAlive Granules is MQV.

Other records listing Bonalive Biomaterials, 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.

K231528Bonalive Orthopedics granules

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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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