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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, Multiple Component
510(k) Number K901272
Device Name ORION BLADE PLATE FOR TIBIAL OSTEOTOMY
Applicant
Med-Tek Corp.
6535 E. 82nd St.
Suite 215
Indianapolis,  IN  46250
Applicant Contact KENNETH EPLING
Correspondent
Med-Tek Corp.
6535 E. 82nd St.
Suite 215
Indianapolis,  IN  46250
Correspondent Contact KENNETH EPLING
Regulation Number888.3030
Classification Product Code
KTT  
Date Received03/19/1990
Decision Date 04/23/1990
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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