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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 K052237
Device Name SC CERAMIC BALL HEADS
Applicant
Orthopedic Alliance, LLC
41558 Eastman Dr., Suite A
Murrieta,  CA  92562
Applicant Contact HARTMUT LOCH
Correspondent
Orthopedic Alliance, LLC
41558 Eastman Dr., Suite A
Murrieta,  CA  92562
Correspondent Contact HARTMUT LOCH
Regulation Number888.3353
Classification Product Code
LZO  
Date Received08/17/2005
Decision Date 09/06/2005
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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