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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K083458
Device Name INTRAMEDULLARY FIXATION ROD (IFS)
Applicant
Novalign Orthopaedics, Inc.
5885 Rigdeway Center Pkwy.
Suite 210
Memphis,  TN  38104
Applicant Contact JEFFREY G ROBERTS
Correspondent
Novalign Orthopaedics, Inc.
5885 Rigdeway Center Pkwy.
Suite 210
Memphis,  TN  38104
Correspondent Contact JEFFREY G ROBERTS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/21/2008
Decision Date 02/09/2009
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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