FDA 510(k) Application Details - K111957

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K111957
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	BIOMET SPINE (EBI LLC) 100 INTERPACE PARKWAY PARSIPPANY, NJ 07540 US Other 510(k) Applications for this Company
Contact	VIVIAN KELLY, RAC Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2011
Decision Date	08/19/2011
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