FDA 510(k) Application Details - K030087

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K030087
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	SPINAL CONCEPTS, INC. 5301 RIATA PARK COURT BLDG F AUSTIN, TX 78727 US Other 510(k) Applications for this Company
Contact	LISA PETERSON 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	01/09/2003
Decision Date	07/17/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review