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 Bone Wedge
510(k) Number K223226
Device Name Trigon™ HA Stand-Alone Wedge Fixation System
Applicant
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma
San Antonio,  TX  78249
Applicant Contact Diana Langham
Correspondent
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma
San Antonio,  TX  78249
Correspondent Contact Analaura Villarreal-Berain
Regulation Number888.3030
Classification Product Code
PLF  
Subsequent Product Code
HWC  
Date Received10/18/2022
Decision Date 12/01/2022
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
-
-