FDA 510(k) Application Details - K121727

Device Classification Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive   More FDA Info for this Device
510(K) Number	K121727
Device Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Applicant	ENCORE MEDICAL, L.P. 9800 METRIC BLVD. AUSTIN, TX 78758 US Other 510(k) Applications for this Company
Contact	WILLIAM GARZON Other 510(k) Applications for this Contact
Regulation Number	888.3560   More FDA Info for this Regulation Number
Classification Product Code	OIY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2012
Decision Date	08/15/2012
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