FDA 510(k) Application Details - K101438

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K101438
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. MAHWAH, NJ 07430 US Other 510(k) Applications for this Company
Contact	MELISSA MATARESE 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	05/24/2010
Decision Date	06/17/2010
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