FDA 510(k) Application Details - K133369

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K133369
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	CORELINK 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	NKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2013
Decision Date	01/14/2014
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