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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 K072101
Device Name RIGI-FIX HIP STEM SYSTEM
Applicant
Implants Intl. , Ltd.
71 Jay Ave.
Teesside Industrial Est.
Thornaby-On-Tees,  GB T517 9LZ
Applicant Contact MOHAN EMMANUEL
Correspondent
Implants Intl. , Ltd.
71 Jay Ave.
Teesside Industrial Est.
Thornaby-On-Tees,  GB T517 9LZ
Correspondent Contact MOHAN EMMANUEL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
MEH  
Date Received07/31/2007
Decision Date 11/19/2007
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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