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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, cemented
510(k) Number K191414
Device Name EXETER Centralizer, EXETER 2.5mm Plug
Applicant
Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Denise Daugert
Correspondent
Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Denise Daugert
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LZN  
Date Received05/28/2019
Decision Date 08/28/2019
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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