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FDA 510(k)

ABCcolla Bone Matrix

K-Number: K212156 · 2021-10-08

ApplicantAcro Biomedical Co., Ltd.
Decision Date2021-10-08
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ABCcolla Bone Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Acro Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K212156. 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 ABCcolla Bone Matrix?

ABCcolla Bone Matrix is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Acro Biomedical Co., Ltd.. The 510(k) number is K212156.

When did ABCcolla Bone Matrix receive FDA 510(k) clearance?

ABCcolla Bone Matrix received FDA 510(k) clearance on 2021-10-08, under 510(k) number K212156.

Who is the listed applicant for ABCcolla Bone Matrix?

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

What is the FDA product code for ABCcolla Bone Matrix?

The FDA product code for ABCcolla Bone Matrix is MQV.

Other records listing Acro Biomedical Co., Ltd. as applicant

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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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