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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, femoral component, cemented, metal
510(k) Number K173499
Device Name Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
Applicant
Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Kirsten Lehmuller
Correspondent
Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Kirsten Lehmuller
Regulation Number888.3360
Classification Product Code
JDG  
Subsequent Product Codes
JDI   KWY   LZO  
Date Received11/13/2017
Decision Date 03/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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