FDA 510(k)

Artisan Bone Plug, Universal Cement Restrictor

K-Number: K220838 · 2022-05-20

ApplicantHowmedica Osteonics, Dba Stryker Orthopaedics

Decision Date2022-05-20

Product CodeLZN

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Artisan Bone Plug, Universal Cement Restrictor is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics, Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2022-05-20 under 510(k) number K220838. The device is classified under product code LZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Artisan Bone Plug, Universal Cement Restrictor?

Artisan Bone Plug, Universal Cement Restrictor is a medical device that received FDA 510(k) clearance on 2022-05-20. The listed applicant is Howmedica Osteonics, Dba Stryker Orthopaedics. The 510(k) number is K220838.

When did Artisan Bone Plug, Universal Cement Restrictor receive FDA 510(k) clearance?

Artisan Bone Plug, Universal Cement Restrictor received FDA 510(k) clearance on 2022-05-20, under 510(k) number K220838.

Who is the listed applicant for Artisan Bone Plug, Universal Cement Restrictor?

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

What is the FDA product code for Artisan Bone Plug, Universal Cement Restrictor?

The FDA product code for Artisan Bone Plug, Universal Cement Restrictor is LZN.

Related Clinical Trials

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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.