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 System, Facet Screw Spinal Device
510(k) Number K253432
Device Name DiversiVy™ Facet Screw System
Applicant
Vy Spine, LLC
545 W 500 S.
Suite 100
Bountiful,  UT  84010
Applicant Contact Jordan Hendrickson
Correspondent
Vy Spine, LLC
545 W 500 S.
Suite 100
Bountiful,  UT  84010
Correspondent Contact Jordan Hendrickson
Classification Product Code
MRW  
Date Received10/01/2025
Decision Date 03/19/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-