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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K170339
Device Name Summit Hip System
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.,
Warsaw,  IN  46582
Applicant Contact Carol S. Ming
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.,
Warsaw,  IN  46582
Correspondent Contact Daniel J. Williman
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWL   KWY   LPH   LWJ  
LZY   MEH  
Date Received02/02/2017
Decision Date 04/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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