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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, porous uncemented
510(k) Number K233498
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 Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
HRS   HWC   JDG   JDI   JDQ  
KWL   KWY   KWZ   LRN   LWJ   LYT  
LZN   LZO   MAY   MBL   MEH  
Date Received10/31/2023
Decision Date 12/21/2023
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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