FDA 510(k) Application Details - K061978

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K061978
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	EBI, L.P. 399 JEFFERSON ROAD PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	DEBRA BING Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2006
Decision Date	08/11/2006
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