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FDA 510(k)

CEMEX SYSTEM GUN APPLICATION VERSION

K-Number: K000943 · 2001-02-08

ApplicantExactech, Inc.
Decision Date2001-02-08
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CEMEX SYSTEM GUN APPLICATION VERSION is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2001-02-08 under 510(k) number K000943. 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 GUN APPLICATION VERSION?

CEMEX SYSTEM GUN APPLICATION VERSION is a medical device that received FDA 510(k) clearance on 2001-02-08. The listed applicant is Exactech, Inc.. The 510(k) number is K000943.

When did CEMEX SYSTEM GUN APPLICATION VERSION receive FDA 510(k) clearance?

CEMEX SYSTEM GUN APPLICATION VERSION received FDA 510(k) clearance on 2001-02-08, under 510(k) number K000943.

Who is the listed applicant for CEMEX SYSTEM GUN APPLICATION VERSION?

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 GUN APPLICATION VERSION?

The FDA product code for CEMEX SYSTEM GUN APPLICATION VERSION 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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