FDA 510(k) Application Details - K082797

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K082797
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	WHITNEY G TORNING 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	09/23/2008
Decision Date	10/17/2008
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