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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, Spinal Interlaminal
510(k) Number K140645
Device Name GIBRALT ROD-TO-ROD CROSS CONNECTORS
Applicant
Exactech Sarasota
7455 16th St. E.
Suite 105
Sarasota,  FL  34243
Applicant Contact PATRICK HUGHES
Correspondent
Exactech Sarasota
7455 16th St. E.
Suite 105
Sarasota,  FL  34243
Correspondent Contact PATRICK HUGHES
Regulation Number888.3050
Classification Product Code
KWP  
Date Received03/13/2014
Decision Date 04/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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