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FDA 510(k)

ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES

K-Number: K082575 · 2008-11-25

ApplicantApatech , Ltd.
Decision Date2008-11-25
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES is the device name listed in this FDA 510(k) record. The listed applicant is Apatech , Ltd.. It received FDA 510(k) clearance on 2008-11-25 under 510(k) number K082575. 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 BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES?

ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES is a medical device that received FDA 510(k) clearance on 2008-11-25. The listed applicant is Apatech , Ltd.. The 510(k) number is K082575.

When did ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES receive FDA 510(k) clearance?

ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES received FDA 510(k) clearance on 2008-11-25, under 510(k) number K082575.

Who is the listed applicant for ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES?

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 BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES?

The FDA product code for ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES 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 SUBSTITUTEK081979ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTEK082073ACTIFUSE FLOW BONE GRAFT SUBSTITUTEK080736ACTIFUSE SHAPE BONE GRAFT SUBSTITUTEK071206ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTEK040082PORE-SI BONE GRAFT SUBSTITUTE

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Related Devices (Code: MQV)

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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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