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FDA 510(k)

Bonalive Orthopedics granules

K-Number: K231528 · 2023-07-11

ApplicantBonalive Biomaterials, Ltd.
Decision Date2023-07-11
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Bonalive Orthopedics 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 2023-07-11 under 510(k) number K231528. 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 Orthopedics granules?

Bonalive Orthopedics granules is a medical device that received FDA 510(k) clearance on 2023-07-11. The listed applicant is Bonalive Biomaterials, Ltd.. The 510(k) number is K231528.

When did Bonalive Orthopedics granules receive FDA 510(k) clearance?

Bonalive Orthopedics granules received FDA 510(k) clearance on 2023-07-11, under 510(k) number K231528.

Who is the listed applicant for Bonalive Orthopedics 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 Orthopedics granules?

The FDA product code for Bonalive Orthopedics 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.

K191274BonAlive Granules

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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