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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 K163585
Device Name Responsive Orthopedics Total Hip Arthroplasty System
Applicant
Responsive Orthopedics, LLC
5865 E State Road 14
Columbia City,  IN  46725
Applicant Contact Kathy Remsen
Correspondent
Medtronic, Inc.
2600 Sofamor Danek Drive
Memphis,  TN  38132
Correspondent Contact Kathy Remsen
Regulation Number888.3353
Classification Product Code
LZO  
Date Received12/20/2016
Decision Date 06/02/2017
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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