FDA 510(k) Application Details - K103332

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K103332
Device Name	Plate, Fixation, Bone
Applicant	MEDARTIS AG 11234 EL CAMINO REAL, SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	KEVIN A THOMAS Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2010
Decision Date	01/24/2011
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