FDA 510(k) Application Details - K122529

Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

  More FDA Info for this Device
510(K) Number K122529
Device Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Applicant ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
Other 510(k) Applications for this Company
Contact MARK D WARNER
Other 510(k) Applications for this Contact
Regulation Number 888.3520

  More FDA Info for this Regulation Number
Classification Product Code HSX
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/20/2012
Decision Date 11/16/2012
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact