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FDA 510(k)

OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE

K-Number: K043420 · 2005-02-10

ApplicantRegeneration Technologies, Inc.
Decision Date2005-02-10
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Regeneration Technologies, Inc.. It received FDA 510(k) clearance on 2005-02-10 under 510(k) number K043420. 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 OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE?

OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE is a medical device that received FDA 510(k) clearance on 2005-02-10. The listed applicant is Regeneration Technologies, Inc.. The 510(k) number is K043420.

When did OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE receive FDA 510(k) clearance?

OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE received FDA 510(k) clearance on 2005-02-10, under 510(k) number K043420.

Who is the listed applicant for OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE?

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

What is the FDA product code for OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE?

The FDA product code for OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE is MQV.

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Other records listing Regeneration Technologies, Inc. as applicant

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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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