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FDA 510(k)

ABCcolla Bone Matrix

K-Number: K212156 · 2021-10-08

Decision Date2021-10-08
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ABCcolla Bone Matrix is a medical device manufactured by Acro Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2021-10-08 under approval 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. It is manufactured by Acro Biomedical Co., Ltd.. The 510(k) number is K212156.

When was ABCcolla Bone Matrix approved by the FDA?

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

What company makes ABCcolla Bone Matrix?

ABCcolla Bone Matrix is manufactured by Acro Biomedical Co., Ltd..

What is the FDA product code for ABCcolla Bone Matrix?

The FDA product code for ABCcolla Bone Matrix is MQV.

Other Devices by Acro Biomedical Co., Ltd.

Related Devices (Code: MQV)

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.