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 Staple, Fixation, Bone
510(k) Number K232324
Device Name StealthFix Intraosseous Fixation System
Applicant
Medartis, Inc.
1195 Polk Dr.
Warsaw,  IN  46582
Applicant Contact Chelsea Kozior
Correspondent
Medartis, Inc.
1195 Polk Dr.
Warsaw,  IN  46582
Correspondent Contact Chelsea Kozior
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Code
HWC  
Date Received08/03/2023
Decision Date 08/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-