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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 K870786
Device Name AXIAL COMPRESSION SCREW
Applicant
Straub Clinic and Hospital
888 S. King St.
Honolulu,  HI  96813
Applicant Contact ROBERT J MEDOFF
Correspondent
Straub Clinic and Hospital
888 S. King St.
Honolulu,  HI  96813
Correspondent Contact ROBERT J MEDOFF
Regulation Number888.3030
Classification Product Code
KTT  
Date Received02/26/1987
Decision Date 06/01/1987
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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