FDA 510(k) Application Details - K110906

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K110906
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	SPINECRAFT LLC 2215 ENTERPRISE DRIVE SUITE 1504 WESTCHESTER, IL 60154 US Other 510(k) Applications for this Company
Contact	AMI AKALLAL-ASAAD 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	03/31/2011
Decision Date	07/26/2011
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