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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/Polymer, Cemented
510(k) Number K910093
Device Name FUTURA FEMORAL HIP STEM
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 Number888.3350
Classification Product Code
JDI  
Date Received01/08/1991
Decision Date 07/01/1991
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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