FDA 510(k) Application Details - K080992

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K080992
Device Name	Plate, Fixation, Bone
Applicant	AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US Other 510(k) Applications for this Company
Contact	Lisa Boyle 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	04/07/2008
Decision Date	09/04/2008
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