FDA 510(k) Application Details - K062085

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K062085
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	AESCULAP 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US Other 510(k) Applications for this Company
Contact	KATHY A RACOSKY 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	07/21/2006
Decision Date	03/02/2007
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