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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 K100445
Device Name KLASSIC HD HIP SYSTEM
Applicant
Total Joint Orthopedics, Inc.
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Applicant Contact KIT CARIQUITAN
Correspondent
Total Joint Orthopedics, Inc.
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Correspondent Contact KIT CARIQUITAN
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
LWJ   MBL  
Date Received02/17/2010
Decision Date 12/03/2010
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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