FDA 510(k) Application Details - K100312

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K100312
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	DGIMED ORTHO, INC 12400 WHITEWATER DRIVE, SUITE 2010 MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	SCOTT P YOUNGSTROM 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	02/04/2010
Decision Date	04/20/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review