• 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 plate, fixation, bone
510(k) Number K190953
Device Name Arthrex Minimally Invasive Ankle Fusion Plate
Applicant
Arthrex, Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Applicant Contact Caroline Bloemker
Correspondent
Arthrex, Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact Caroline Bloemker
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/11/2019
Decision Date 10/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-