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FDA 510(k)

CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

K-Number: K013072 · 2002-11-26

ApplicantSynthes
Decision Date2002-11-26
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) is the device name listed in this FDA 510(k) record. The listed applicant is Synthes. It received FDA 510(k) clearance on 2002-11-26 under 510(k) number K013072. 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 CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)?

CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) is a medical device that received FDA 510(k) clearance on 2002-11-26. The listed applicant is Synthes. The 510(k) number is K013072.

When did CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) receive FDA 510(k) clearance?

CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) received FDA 510(k) clearance on 2002-11-26, under 510(k) number K013072.

Who is the listed applicant for CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)?

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

What is the FDA product code for CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)?

The FDA product code for CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) is MQV.

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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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