FDA 510(k) Application Details - K110354

Device Classification Name	Condylar Plate Fixation Implant   More FDA Info for this Device
510(K) Number	K110354
Device Name	Condylar Plate Fixation Implant
Applicant	SYNTHES USA 1301 GOSHEN PKWY WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	THOMAS N SHEA Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2011
Decision Date	03/04/2011
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