FDA 510(k) Application Details - K062301

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

  More FDA Info for this Device
510(K) Number K062301
Device Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Applicant DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DR.
P.O BOX 988
WARSAW, IN 46581-0988 US
Other 510(k) Applications for this Company
Contact NANCY FRIDDLE
Other 510(k) Applications for this Contact
Regulation Number 888.3510

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

  More FDA Info for this Product Code
Date Received 08/08/2006
Decision Date 10/13/2006
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