FDA 510(k) Application Details - K110552

Device Classification Name Rod, Fixation, Intramedullary And Accessories

  More FDA Info for this Device
510(K) Number K110552
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
Other 510(k) Applications for this Company
Contact RYAN BORMANN
Other 510(k) Applications for this Contact
Regulation Number 888.3020

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

  More FDA Info for this Product Code
Date Received 02/28/2011
Decision Date 03/23/2011
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