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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K234025
Device Name 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads
Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact Meenakshi Verma
Correspondent
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact Meenakshi Verma
Regulation Number888.3353
Classification Product Code
LZO  
Date Received12/20/2023
Decision Date 04/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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