FDA 510(k) Application Details - K992346

Device Classification Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing   More FDA Info for this Device
510(K) Number	K992346
Device Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
Applicant	HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH ALLENDALE, NJ 07401-1677 US Other 510(k) Applications for this Company
Contact	KAREN ARIEMMA Other 510(k) Applications for this Contact
Regulation Number	888.3530   More FDA Info for this Regulation Number
Classification Product Code	LGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/1999
Decision Date	08/12/1999
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