FDA 510(k) Application Details - K080841

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K080841
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	ULRICH GMBH & CO. KG 754 SPIRIT 40 PARK DRIVE ST. LOUIS, MO 63005 US Other 510(k) Applications for this Company
Contact	MERLE SYMES 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	03/26/2008
Decision Date	07/23/2008
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