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FDA 510(k)

CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL

K-Number: K021715 · 2002-06-12

ApplicantExactech, Inc.
Decision Date2002-06-12
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2002-06-12 under 510(k) number K021715. 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 RX, CEMEX ISOPLASTIC & CEMEX XL?

CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL is a medical device that received FDA 510(k) clearance on 2002-06-12. The listed applicant is Exactech, Inc.. The 510(k) number is K021715.

When did CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL receive FDA 510(k) clearance?

CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL received FDA 510(k) clearance on 2002-06-12, under 510(k) number K021715.

Who is the listed applicant for CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL?

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 RX, CEMEX ISOPLASTIC & CEMEX XL?

The FDA product code for CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL 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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