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FDA 510(k)

GRAFTCAGE ACX

K-Number: K053080 · 2005-12-01

ApplicantOsteotech, Inc.
Decision Date2005-12-01
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GRAFTCAGE ACX is the device name listed in this FDA 510(k) record. The listed applicant is Osteotech, Inc.. It received FDA 510(k) clearance on 2005-12-01 under 510(k) number K053080. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAFTCAGE ACX?

GRAFTCAGE ACX is a medical device that received FDA 510(k) clearance on 2005-12-01. The listed applicant is Osteotech, Inc.. The 510(k) number is K053080.

When did GRAFTCAGE ACX receive FDA 510(k) clearance?

GRAFTCAGE ACX received FDA 510(k) clearance on 2005-12-01, under 510(k) number K053080.

Who is the listed applicant for GRAFTCAGE ACX?

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

What is the FDA product code for GRAFTCAGE ACX?

The FDA product code for GRAFTCAGE ACX is MQP.

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Other records listing Osteotech, Inc. 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.

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Related Devices (Code: MQP)

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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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