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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, hemi-, femoral, metal
510(k) Number K222632
Device Name UHR Bipolar Implants, Restoration GAP II Implants
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 Number888.3360
Classification Product Code
KWL  
Subsequent Product Codes
JDI   LZO  
Date Received08/31/2022
Decision Date 10/21/2022
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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