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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K905357
Device Name CORTICAL BONE SCREW (EUROPEAN STYLE)
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 Number888.3040
Classification Product Code
HWC  
Date Received11/28/1990
Decision Date 01/04/1991
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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