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FDA 510(k)

TRIDENT HEMISPHERICAL ACETABULAR SHELLS

K-Number: K013676 · 2001-12-05

ApplicantHowmedica Osteonics Corp.
Decision Date2001-12-05
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIDENT HEMISPHERICAL ACETABULAR SHELLS 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 2001-12-05 under 510(k) number K013676. 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 TRIDENT HEMISPHERICAL ACETABULAR SHELLS?

TRIDENT HEMISPHERICAL ACETABULAR SHELLS is a medical device that received FDA 510(k) clearance on 2001-12-05. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K013676.

When did TRIDENT HEMISPHERICAL ACETABULAR SHELLS receive FDA 510(k) clearance?

TRIDENT HEMISPHERICAL ACETABULAR SHELLS received FDA 510(k) clearance on 2001-12-05, under 510(k) number K013676.

Who is the listed applicant for TRIDENT HEMISPHERICAL ACETABULAR SHELLS?

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 TRIDENT HEMISPHERICAL ACETABULAR SHELLS?

The FDA product code for TRIDENT HEMISPHERICAL ACETABULAR SHELLS is MEH.

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Related Devices (Code: 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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