Artisan Bone Plug, Universal Cement Restrictor— 510(k) K220838

Name: FDA 510(k) clearance K220838
Creator: U.S. Food and Drug Administration
Published: 2022-05-20

Substantially Equivalent

Howmedica Osteonics, Dba Stryker Orthopaedics

FDA 510(k) clearance K220838 for Artisan Bone Plug, Universal Cement Restrictor, Substantially Equivalent on 2022-05-20. Applicant: Howmedica Osteonics, Dba Stryker Orthopaedics. Device class: 2.

Clearance details

Applicant: Howmedica Osteonics, Dba Stryker Orthopaedics
Product code: Code LZN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2022-03-22
Decision date: 2022-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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K023680 — BIOBUCK CEMENT RESTRICTOR2002-11-19
K011943 — IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR2001-09-19
K010840 — SYNPLUG2001-04-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.