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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 K161569
Device Name Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
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 Received06/07/2016
Decision Date 10/14/2016
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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