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FDA 510(k)

ABCcolla Bone Graft

K-Number: K171629 · 2018-02-01

ApplicantAcro Biomedical Co., Ltd.
Decision Date2018-02-01
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ABCcolla Bone Graft 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 2018-02-01 under 510(k) number K171629. 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 Graft?

ABCcolla Bone Graft is a medical device that received FDA 510(k) clearance on 2018-02-01. The listed applicant is Acro Biomedical Co., Ltd.. The 510(k) number is K171629.

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

ABCcolla Bone Graft received FDA 510(k) clearance on 2018-02-01, under 510(k) number K171629.

Who is the listed applicant for ABCcolla Bone Graft?

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 Graft?

The FDA product code for ABCcolla Bone Graft 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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