FDA 510(k) Application Details - K070385

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K070385
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	TI-TAMED (PTY) LTD 54 AUCKLAND STREET PAARDEN EILAND CAPE TOWN, WESTERN CAPE 7405 ZA Other 510(k) Applications for this Company
Contact	SANDRA MORTIMER 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	02/09/2007
Decision Date	07/31/2009
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