FDA 510(k) Application Details - K120557

Device Classification Name	More FDA Info for this Device
510(K) Number	K120557
Device Name	SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35
Applicant	BIOMET SPINE & BONE HEALING TECHNOLOGIES 100 INTERPACE PARKWAY PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	MARGARET F CROWE 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	02/24/2012
Decision Date	03/19/2012
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