FDA 510(k)

TRITANIUM ACETABULAR SHELL SYSTEM

K-Number: K081171 · 2008-07-22

Decision Date2008-07-22

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TRITANIUM ACETABULAR SHELL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2008-07-22 under 510(k) number K081171. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRITANIUM ACETABULAR SHELL SYSTEM?

TRITANIUM ACETABULAR SHELL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-22. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K081171.

When did TRITANIUM ACETABULAR SHELL SYSTEM receive FDA 510(k) clearance?

TRITANIUM ACETABULAR SHELL SYSTEM received FDA 510(k) clearance on 2008-07-22, under 510(k) number K081171.

Who is the listed applicant for TRITANIUM ACETABULAR SHELL SYSTEM?

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

What is the FDA product code for TRITANIUM ACETABULAR SHELL SYSTEM?

The FDA product code for TRITANIUM ACETABULAR SHELL SYSTEM is LPH.

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Related Devices (Code: LPH)

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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.