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FDA 510(k)

APATIGHT-TCP BONE GRAFT SUBSTITUTE

K-Number: K013966 · 2002-05-16

ApplicantCerabio, LLC
Decision Date2002-05-16
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APATIGHT-TCP BONE GRAFT SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Cerabio, LLC. It received FDA 510(k) clearance on 2002-05-16 under 510(k) number K013966. 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 APATIGHT-TCP BONE GRAFT SUBSTITUTE?

APATIGHT-TCP BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2002-05-16. The listed applicant is Cerabio, LLC. The 510(k) number is K013966.

When did APATIGHT-TCP BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

APATIGHT-TCP BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2002-05-16, under 510(k) number K013966.

Who is the listed applicant for APATIGHT-TCP BONE GRAFT SUBSTITUTE?

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

What is the FDA product code for APATIGHT-TCP BONE GRAFT SUBSTITUTE?

The FDA product code for APATIGHT-TCP BONE GRAFT SUBSTITUTE is MQV.

Related Clinical Trials

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Other records listing Cerabio, LLC 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.

K013960APATIGHT HA-BONE GRAFT SUBSTITUTE

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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