FDA 510(k) Application Details - K043484

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K043484
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	LANX, LLC 200 GREGORY LANE SUITE C-100 PLEASANT HILL, CA 94523-3389 US Other 510(k) Applications for this Company
Contact	DAVID W SCHLERF 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	12/17/2004
Decision Date	05/16/2005
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