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 K250641
Device Name APEX 3D Total Ankle Replacement System
Applicant
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Applicant Contact Edward Wells-Spicer
Correspondent
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Correspondent Contact Edward Wells-Spicer
Regulation Number888.3110
Classification Product Code
HSN  
Date Received03/04/2025
Decision Date 05/01/2025
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
-
-