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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 K905338
Device Name SIDE PLATE
Applicant
O'Tec Corp.
6685 Quince
Suite 106
Memphis,  TN  38119
Applicant Contact RICARDO HEROS
Correspondent
O'Tec Corp.
6685 Quince
Suite 106
Memphis,  TN  38119
Correspondent Contact RICARDO HEROS
Regulation Number888.3030
Classification Product Code
KTT  
Date Received11/28/1990
Decision Date 12/11/1990
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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