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FDA 510(k)

CERMET III ACETABULAR CUP SYSTEM

K-Number: K071583 · 2007-07-25

ApplicantImplants International, Ltd.
Decision Date2007-07-25
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CERMET III ACETABULAR CUP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implants International, Ltd.. It received FDA 510(k) clearance on 2007-07-25 under 510(k) number K071583. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERMET III ACETABULAR CUP SYSTEM?

CERMET III ACETABULAR CUP SYSTEM is a medical device that received FDA 510(k) clearance on 2007-07-25. The listed applicant is Implants International, Ltd.. The 510(k) number is K071583.

When did CERMET III ACETABULAR CUP SYSTEM receive FDA 510(k) clearance?

CERMET III ACETABULAR CUP SYSTEM received FDA 510(k) clearance on 2007-07-25, under 510(k) number K071583.

Who is the listed applicant for CERMET III ACETABULAR CUP SYSTEM?

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

What is the FDA product code for CERMET III ACETABULAR CUP SYSTEM?

The FDA product code for CERMET III ACETABULAR CUP SYSTEM is MEH.

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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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