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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 K133228
Device Name ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM
Applicant
Iconacy Orthopedic Implants, LLC
4130 Corridor Dr.
Warsaw,  IN  46582
Applicant Contact MARC E RUHLING
Correspondent
Iconacy Orthopedic Implants, LLC
4130 Corridor Dr.
Warsaw,  IN  46582
Correspondent Contact MARC E RUHLING
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LWJ  
Date Received10/21/2013
Decision Date 01/17/2014
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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