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 K202099
Device Name AOS Galileo™ Trochanteric Nail System
Applicant
Advanced Orthopaedic Solutions, Inc.
3203 Kashiwa St.
Torrance,  CA  90505
Applicant Contact Jolie Krance
Correspondent
Advanced Orthopaedic Solutions, Inc.
3203 Kashiwa St.
Torrance,  CA  90505
Correspondent Contact Jolie Krance
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/29/2020
Decision Date 08/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-