FDA 510(k) Application Details - K040346

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K040346
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	ORTHOTEC, L.L.C. 9595 WILSHIRE BLVD. SUITE 502 BEVERLY HILLS, CA 90212 US Other 510(k) Applications for this Company
Contact	PATRICK BERTRANOU 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	02/12/2004
Decision Date	03/12/2004
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