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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
510(k) Number K862279
Device Name EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM
Applicant
Orthospec, Inc.
500 Airport Executive Park
Spring Valley,  NY  10977
Applicant Contact VICTOR F BANKO
Correspondent
Orthospec, Inc.
500 Airport Executive Park
Spring Valley,  NY  10977
Correspondent Contact VICTOR F BANKO
Regulation Number888.3030
Classification Product Code
KTW  
Date Received06/16/1986
Decision Date 07/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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