FDA 510(k) Application Details - K081790

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K081790
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	TRINITY ORTHOPEDICS, LLC 11234 EL CAMINO REAL SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	KEVIN A THOMAS 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	06/25/2008
Decision Date	07/24/2008
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