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 K243888
Device Name Medline UNITE® REFLEX® Hybrid Nitinol Implant System
Applicant
Medline Industries, LP
Three Lakes Dr.
Northfield,  IL  60030
Applicant Contact Jennifer Mason
Correspondent
Medline Industries, LP
Three Lakes Dr.
Northfield,  IL  60030
Correspondent Contact Jennifer Mason
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Code
HWC  
Date Received12/18/2024
Decision Date 04/11/2025
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
-
-