Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K141571
Device Name ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM
Applicant
Orthofix Srl
3451 Plano Pkwy.
Lweisville,  TX  75056
Applicant Contact TROY BROOKS
Correspondent
Orthofix Srl
3451 Plano Pkwy.
Lweisville,  TX  75056
Correspondent Contact TROY BROOKS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/12/2014
Decision Date 11/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-