FDA 510(k) Application Details - K083458

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K083458
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	NOVALIGN ORTHOPAEDICS, INC 5885 RIGDEWAY CENTER PARKWAY SUITE 210 MEMPHIS, TN 38104 US Other 510(k) Applications for this Company
Contact	JEFFREY G ROBERTS Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2008
Decision Date	02/09/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review