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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, femorotibial, constrained, cemented, metal/polymer
510(k) Number K223069
Device Name Modular Rotating Hinge Knee Systems and Compatible Components
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 Number888.3510
Classification Product Code
KRO  
Subsequent Product Codes
JWH   LGE  
Date Received09/30/2022
Decision Date 04/21/2023
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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