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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 K082833
Device Name NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
Applicant
NUTEK ORTHOPAEDICS, INC.
16771 SW 6TH ST.
PEMBROKE PINES,  FL  33027
Applicant Contact PETER MINCIELLI
Correspondent
NUTEK ORTHOPAEDICS, INC.
16771 SW 6TH ST.
PEMBROKE PINES,  FL  33027
Correspondent Contact PETER MINCIELLI
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
LXT  
Date Received09/26/2008
Decision Date 02/05/2009
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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