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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 K060026
Device Name KOBY SURGICAL INTERNAL FIXATION SYSTEM
Applicant
Koby Surgical
16350 Park Ten Pl., Suite 101
Houston,  TX  77084
Applicant Contact PERRY FORRESTER
Correspondent
Koby Surgical
16350 Park Ten Pl., Suite 101
Houston,  TX  77084
Correspondent Contact PERRY FORRESTER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/04/2006
Decision Date 01/26/2006
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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