FDA 510(k) Application Details - K041355

Device Classification Name Pin, Fixation, Smooth

  More FDA Info for this Device
510(K) Number K041355
Device Name Pin, Fixation, Smooth
Applicant SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova, TN 38016 US
Other 510(k) Applications for this Company
Contact JOHN REABE
Other 510(k) Applications for this Contact
Regulation Number 888.3040

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

  More FDA Info for this Product Code
Date Received 05/20/2004
Decision Date 07/30/2004
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