FDA 510(k) Application Details - K083178

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K083178
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	BIOTECHNI AMERICA SPINE GROUP, INC. 13203 39TH AVE. NE SEATTLE, WA 98125-4615 US Other 510(k) Applications for this Company
Contact	DANIEL R BAKER 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	10/28/2008
Decision Date	02/23/2009
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