FDA 510(k) Application Details - K172785

Device Classification Name Device, Fixation, Proximal Femoral, Implant

  More FDA Info for this Device
510(K) Number K172785
Device Name Device, Fixation, Proximal Femoral, Implant
Applicant Smith & Nephew
1450 E Brooks Road
Memphis, TN 38116 US
Other 510(k) Applications for this Company
Contact Allison Chan
Other 510(k) Applications for this Contact
Regulation Number 888.3030

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

  More FDA Info for this Product Code
Date Received 09/15/2017
Decision Date 12/22/2017
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