FDA 510(k) Application Details - K111145

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal Ball   More FDA Info for this Device
510(K) Number	K111145
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Applicant	MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 US Other 510(k) Applications for this Company
Contact	ADAM GROSS Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	LZY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2011
Decision Date	08/16/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review