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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K971453
Device Name ORTHOTEC K-CAP SYSTEM
Applicant
Orthotech
1053 Koloa St.
Honolulu,  HI  96816
Applicant Contact PATRICK BERTRANOU
Correspondent
Orthotech
1053 Koloa St.
Honolulu,  HI  96816
Correspondent Contact PATRICK BERTRANOU
Regulation Number888.3040
Classification Product Code
HTY  
Date Received04/21/1997
Decision Date 06/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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