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 Screw, Fixation, Bone
510(k) Number K252312
Device Name Eleganz IM Threaded Nail System (IM Threaded Nail System)
Applicant
Dev4
1002 Gemini St., Suite 129
Houston,  TX  77058
Applicant Contact Jeff Seavey
Correspondent
Dev4
1002 Gemini St., Suite 129
Houston,  TX  77058
Correspondent Contact Lance Terrill
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/24/2025
Decision Date 10/10/2025
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
-
-