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 Shoulder Prosthesis, Reverse Configuration
510(k) Number K253992
Device Name Veritas Reverse Total Shoulder System
Applicant
Restor3D
4001 Nc-54 Hwy.
Suite 2160
Durham,  NC  27709
Applicant Contact Brianna Prindle
Correspondent
Restor3D
4001 Nc-54 Hwy.
Suite 2160
Durham,  NC  27709
Correspondent Contact Brianna Prindle
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
QHE  
Date Received12/12/2025
Decision Date 05/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-