FDA 510(k) Application Details - K955778

Device Classification Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K955778
Device Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Applicant	INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. AUSTIN, TX 78717 US Other 510(k) Applications for this Company
Contact	MITCHELL A DHORITY Other 510(k) Applications for this Contact
Regulation Number	888.3530   More FDA Info for this Regulation Number
Classification Product Code	HRY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/1995
Decision Date	03/08/1996
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review