FDA 510(k) Application Details - K111437

Device Classification Name	Reamer   More FDA Info for this Device
510(K) Number	K111437
Device Name	Reamer
Applicant	SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	ANGELA F LASSANDRO Other 510(k) Applications for this Contact
Regulation Number	888.4540   More FDA Info for this Regulation Number
Classification Product Code	HTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2011
Decision Date	08/10/2011
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