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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 K191358
Device Name Trident II Acetabular System
Applicant
Howmedica Osteonics Corp. aka Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Valerie Giambanco
Correspondent
Howmedica Osteonics Corp. aka Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Valerie Giambanco
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWZ   LZO   MEH  
Date Received05/21/2019
Decision Date 10/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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