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 Ankle Arthroplasty Implantation System
510(k) Number K193432
Device Name Vantage PSI System
Applicant
3D Systems
5381 S. Alkire Cir.
Littleton,  CO  80127
Applicant Contact Kim Torluemke
Correspondent
3D Systems
5381 S. Alkire Cir.
Littleton,  CO  80127
Correspondent Contact Kim Torluemke
Regulation Number888.3110
Classification Product Code
OYK  
Date Received12/10/2019
Decision Date 11/09/2020
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
-
-