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FDA 510(k)

TRIDENT CONSTRAINED ACETABULAR INSERT

K-Number: K061654 · 2006-07-07

ApplicantHowmedica Osteonics Corp.
Decision Date2006-07-07
Product CodeKWZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIDENT CONSTRAINED ACETABULAR INSERT 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 2006-07-07 under 510(k) number K061654. The device is classified under product code KWZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIDENT CONSTRAINED ACETABULAR INSERT?

TRIDENT CONSTRAINED ACETABULAR INSERT is a medical device that received FDA 510(k) clearance on 2006-07-07. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K061654.

When did TRIDENT CONSTRAINED ACETABULAR INSERT receive FDA 510(k) clearance?

TRIDENT CONSTRAINED ACETABULAR INSERT received FDA 510(k) clearance on 2006-07-07, under 510(k) number K061654.

Who is the listed applicant for TRIDENT CONSTRAINED ACETABULAR INSERT?

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 CONSTRAINED ACETABULAR INSERT?

The FDA product code for TRIDENT CONSTRAINED ACETABULAR INSERT is KWZ.

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Related Devices (Code: KWZ)

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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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