FDA 510(k) Application Details - K113755

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K113755
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	SAVANNAH TECHNOLOGIES LLC 1001 OAKWOOD BLVD. ROUND ROCK, TX 78681 US Other 510(k) Applications for this Company
Contact	J.D. WEBB 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	12/21/2011
Decision Date	02/01/2012
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