FDA 510(k) Application Details - K093936

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K093936
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 GENEVA 1215 CH Other 510(k) Applications for this Company
Contact	FRANCK PENNESI 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	12/22/2009
Decision Date	03/11/2010
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