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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 K171962
Device Name Klassic HD® Hip System
Applicant
Total Joint Othopedics, Inc.
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Applicant Contact Chris Weaber
Correspondent
Total Joint Othopedics, Inc.
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Correspondent Contact Chris Weaber
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
LZO   MBL  
Date Received06/30/2017
Decision Date 07/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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