FDA 510(k) Application Details - K121568

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K121568
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	ACCEL SPINE 14850 Quorum Dr Ste 220 Dallas, TX 75254 US Other 510(k) Applications for this Company
Contact	DANIEL CHON 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	05/29/2012
Decision Date	09/21/2012
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