FDA 510(k) Application Details - K100112

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K100112
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	SONOMA ORTHOPEDIC PRODUCTS, INC. 650 LARKFIELD CENTER SUITE C SANTA ROSA, CA 95403 US Other 510(k) Applications for this Company
Contact	CARLOS GONZALEZ 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	01/14/2010
Decision Date	09/28/2010
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