FDA 510(k) Application Details - K072704

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

  More FDA Info for this Device
510(K) Number K072704
Device Name Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Applicant VALPO ORTHOPEDIC TECHNOLOGY, INC.
438 E 200 N
WARSAW, IN 46582 US
Other 510(k) Applications for this Company
Contact HANS STOVER
Other 510(k) Applications for this Contact
Regulation Number 888.3530

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

  More FDA Info for this Product Code
Date Received 09/24/2007
Decision Date 02/19/2008
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