FDA 510(k) Application Details - K113556

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

  More FDA Info for this Device
510(K) Number K113556
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Applicant ZIMMER GMBH
P.O. BOX 708
WARSAW, IN 46581-0708 US
Other 510(k) Applications for this Company
Contact DANIEL J WILLIAM
Other 510(k) Applications for this Contact
Regulation Number 888.3353

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

  More FDA Info for this Product Code
Date Received 12/01/2011
Decision Date 02/17/2012
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



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