FDA 510(k) Application Details - K092011

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K092011
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR 1CADDE NO:5/1 BALGAT ANKARA 06520 TR Other 510(k) Applications for this Company
Contact	NURAY DOGAN Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2009
Decision Date	10/28/2009
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