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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 K233261
Device Name Global Modular Replacement System
Applicant
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact Denise Daugert
Correspondent
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact Denise Daugert
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KRO   LPH  
Date Received09/29/2023
Decision Date 12/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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