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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K243817
Device Name Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert
Applicant
Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Tara Rudrapatna
Correspondent
Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Tara Rudrapatna
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/12/2024
Decision Date 02/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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