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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, hip, semi-constrained, metal/polymer, cemented
510(k) Number K222056
Device Name Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
Applicant
Howmedica Osteonics Corp., dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Margaret Klippel
Correspondent
Howmedica Osteonics Corp., dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Margaret Klippel
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KRO   LPH   LZO  
Date Received07/12/2022
Decision Date 01/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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