FDA 510(k) Application Details - K020677

Device Classification Name Rod, Fixation, Intramedullary And Accessories

  More FDA Info for this Device
510(K) Number K020677
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE, NJ 07401-1677 US
Other 510(k) Applications for this Company
Contact WILLIAM J CYMBALUK
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 03/01/2002
Decision Date 03/29/2002
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