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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 K240418
Device Name Stryker Orthopaedics Hip Systems Labeling Update
Applicant
Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Julia Bally
Correspondent
Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Julia Bally
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
HRS   JDG   JDQ   KWY   LPH  
LRN   LYT   LZO  
Date Received02/13/2024
Decision Date 04/12/2024
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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