FDA 510(k) Application Details - K081395

Device Classification Name	More FDA Info for this Device
510(K) Number	K081395
Device Name	SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM
Applicant	BIOMET SPINE 100 INTERPACE PARKWAY PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	VIVIAN KELLY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/2008
Decision Date	06/25/2008
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