FDA 510(k) Application Details - K965056

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K965056
Device Name	Prosthesis, Hip, Cement Restrictor
Applicant	OSTEONICS CORP. 59 ROUTE 17 ALLENDALE, NJ 07401-1677 US Other 510(k) Applications for this Company
Contact	TERRY SHERIDAN 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	12/18/1996
Decision Date	02/28/1997
Decision	SESE - SUBST EQUIV
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