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FDA 510(k)

TRIDENT ACETABULAR SHELLS: PS-HA

K-Number: K001448 · 2000-08-04

ApplicantHowmedica Osteonics Corp.
Decision Date2000-08-04
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIDENT ACETABULAR SHELLS: PS-HA 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 2000-08-04 under 510(k) number K001448. 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 ACETABULAR SHELLS: PS-HA?

TRIDENT ACETABULAR SHELLS: PS-HA is a medical device that received FDA 510(k) clearance on 2000-08-04. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K001448.

When did TRIDENT ACETABULAR SHELLS: PS-HA receive FDA 510(k) clearance?

TRIDENT ACETABULAR SHELLS: PS-HA received FDA 510(k) clearance on 2000-08-04, under 510(k) number K001448.

Who is the listed applicant for TRIDENT ACETABULAR SHELLS: PS-HA?

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 ACETABULAR SHELLS: PS-HA?

The FDA product code for TRIDENT ACETABULAR SHELLS: PS-HA is MEH.

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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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