FDA 510(k) Application Details - K990345

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K990345
Device Name	Prosthesis, Hip, Cement Restrictor
Applicant	SIGNUS MEDIZINTECHNIK GMBH 27660 WOODSIDE RD. SHOREWOOD, MN 55331 US Other 510(k) Applications for this Company
Contact	THOMAS HOGHAUG Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	JDK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/1999
Decision Date	07/30/1999
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review