FDA 510(k) Application Details - K060731

Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer

  More FDA Info for this Device
510(K) Number K060731
Device Name Prosthesis, Elbow, Hemi-, Radial, Polymer
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
Other 510(k) Applications for this Company
Contact WESLEY L REED
Other 510(k) Applications for this Contact
Regulation Number 888.3170

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

  More FDA Info for this Product Code
Date Received 03/20/2006
Decision Date 04/19/2006
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