FDA 510(k) Application Details - K173710

Device Classification Name Screw, Fixation, Bone

  More FDA Info for this Device
510(K) Number K173710
Device Name Screw, Fixation, Bone
Applicant CrossRoads Extremity Systems, LLC
6055 Primacy Pkwy Suite 140
Memphis, TN 38119 US
Other 510(k) Applications for this Company
Contact Chad Hollis
Other 510(k) Applications for this Contact
Regulation Number 888.3040

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

  More FDA Info for this Product Code
Date Received 12/04/2017
Decision Date 02/12/2018
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