FDA 510(k) Application Details - K070849

Device Classification Name Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

  More FDA Info for this Device
510(K) Number K070849
Device Name Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
Other 510(k) Applications for this Company
Contact NANCY FRIDDLE
Other 510(k) Applications for this Contact
Regulation Number 888.3560

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

  More FDA Info for this Product Code
Date Received 03/28/2007
Decision Date 06/26/2007
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