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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 K041081
Device Name FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
Applicant
Hand Innovations, Inc.
8905 SW 87th Ave.
Miami,  FL  33176 -2227
Applicant Contact AL WEISENBORN
Correspondent
Hand Innovations, Inc.
8905 SW 87th Ave.
Miami,  FL  33176 -2227
Correspondent Contact AL WEISENBORN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received04/26/2004
Decision Date 07/01/2004
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
Recalls CDRH Recalls
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