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 Growing Rod System
510(k) Number K241816
Device Name VerteGlide Spinal Growth Guidance System
Applicant
OrthoPediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46582
Applicant Contact Yan Li
Correspondent
OrthoPediatrics Corp.
2850 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact Yan Li
Regulation Number888.3070
Classification Product Code
PGM  
Subsequent Product Code
OLO  
Date Received06/24/2024
Decision Date 03/14/2025
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
-
-