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 System, Image Processing, Radiological
510(k) Number K261352
Device Name 2D Hip Planning Software
Applicant
One Ortho
Parc Inopolis
206 Rte. De Vourles
Saint-Genis-Laval,  FR 69230
Applicant Contact Theo Vidal
Correspondent
One Ortho
Parc Inopolis
206 Rte. De Vourles
Saint-Genis-Laval,  FR 69230
Correspondent Contact Theo Vidal
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/24/2026
Decision Date 06/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-