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 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K231699
Device Name QUANTUM® Patient Specific Instrumentation (PSI) System
Applicant
In2bones Sas
26 Chemin Du Petit Bois
Ecully,  FR 69130
Applicant Contact Stephan Epinette
Correspondent
In2bones USA
6600 Poplar Ave., Suite 115
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3110
Classification Product Code
HSN  
Subsequent Product Code
OYK  
Date Received06/12/2023
Decision Date 04/23/2024
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
-
-