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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 K182468
Device Name Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
Applicant
Howmedica Osteonics Corp aka Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Shahrir Alam
Correspondent
Howmedica Osteonics Corp aka Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Krutanjali Shah
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LWJ  
LZO   MEH  
Date Received09/10/2018
Decision Date 03/19/2019
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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