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 Plate, Fixation, Bone
510(k) Number K253906
Device Name Xpert Hand
Applicant
Newclip Technics
45 Rue Des Garottières
Haute-Goulaine,  FR 44115
Applicant Contact Gaëlle Gourbière
Correspondent
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Haven,  UT  84401
Correspondent Contact J.D. Webb
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/05/2025
Decision Date 03/11/2026
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
-
-