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 Rod, Fixation, Intramedullary And Accessories
510(k) Number K252025
Device Name Active Intramedullary (AIM) Tibial Nail System
Applicant
Satori Orthopaedics, Inc.
3101 E. Shea Blvd.
Suite 122
Phoenix,  AZ  85028
Applicant Contact Navid Ziran
Correspondent
Fast Consulting Services, LLC
6357 Westview Cir.
Parker,  CO  80134
Correspondent Contact Haylie Fast
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/30/2025
Decision Date 03/04/2026
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
-
-