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FDA 510(k)

ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE

K-Number: K080736 · 2008-04-16

ApplicantApatech , Ltd.
Decision Date2008-04-16
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Apatech , Ltd.. It received FDA 510(k) clearance on 2008-04-16 under 510(k) number K080736. 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 ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE?

ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2008-04-16. The listed applicant is Apatech , Ltd.. The 510(k) number is K080736.

When did ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2008-04-16, under 510(k) number K080736.

Who is the listed applicant for ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE?

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

What is the FDA product code for ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE?

The FDA product code for ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE is MQV.

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Other records listing Apatech , 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.

K090850ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTEK082575ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTESK081979ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTEK082073ACTIFUSE FLOW BONE GRAFT SUBSTITUTEK071206ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTEK040082PORE-SI BONE GRAFT SUBSTITUTE

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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

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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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