FDA 510(k) Application Details - K013444

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K013444
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	SCIEN'TX USA INC. 9800 METRIC BLVD. AUSTIN, TX 78758 US Other 510(k) Applications for this Company
Contact	JOANNA DROEGE 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	10/17/2001
Decision Date	11/16/2001
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