FDA 510(k) Application Details - K082146

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented   More FDA Info for this Device
510(K) Number	K082146
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant	AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PWKY. CENTER VALLEY, PA 18034 US Other 510(k) Applications for this Company
Contact	KATHY A RACOSKY Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	LWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2008
Decision Date	09/09/2008
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