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FDA 510(k)

CEMEX SYSTEM FAST

K-Number: K031430 · 2003-05-22

ApplicantExactech, Inc.
Decision Date2003-05-22
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CEMEX SYSTEM FAST is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2003-05-22 under 510(k) number K031430. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEMEX SYSTEM FAST?

CEMEX SYSTEM FAST is a medical device that received FDA 510(k) clearance on 2003-05-22. The listed applicant is Exactech, Inc.. The 510(k) number is K031430.

When did CEMEX SYSTEM FAST receive FDA 510(k) clearance?

CEMEX SYSTEM FAST received FDA 510(k) clearance on 2003-05-22, under 510(k) number K031430.

Who is the listed applicant for CEMEX SYSTEM FAST?

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

What is the FDA product code for CEMEX SYSTEM FAST?

The FDA product code for CEMEX SYSTEM FAST is LOD.

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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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