FDA 510(k) Application Details - K013818

Device Classification Name	Component, Traction, Invasive   More FDA Info for this Device
510(K) Number	K013818
Device Name	Component, Traction, Invasive
Applicant	AUTOGENESIS, INC. 8700 OLD HARFORD RD. BALTIMORE, MD 21234 US Other 510(k) Applications for this Company
Contact	JAMES EDWARDS Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2001
Decision Date	12/05/2001
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