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 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K183343
Device Name Vantage Total Ankle Flat Cut Talar Components
Applicant
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Applicant Contact Shing Jen Tai
Correspondent
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Correspondent Contact Shing Jen Tai
Regulation Number888.3110
Classification Product Code
HSN  
Date Received12/03/2018
Decision Date 04/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-