FDA 510(k) Application Details - K962646

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal   More FDA Info for this Device
510(K) Number	K962646
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal
Applicant	ORTHOPAEDIC INNOVATIONS, INC. 825 SOUTH 8TH ST. SUITE 700 MINNEAPOLIS, MN 55404 US Other 510(k) Applications for this Company
Contact	CAROLYN M STEELE-HUSTEN Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	KWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/1996
Decision Date	09/23/1996
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