FDA 510(k) Application Details - K013424

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K013424
Device Name	Pin, Fixation, Smooth
Applicant	HAND INNOVATIONS, INC. 8905 SW 87TH AVE. MIAMI, FL 33176-2227 US Other 510(k) Applications for this Company
Contact	AL WEISENBORN Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2001
Decision Date	12/20/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review