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 intervertebral fusion device with bone graft, lumbar
510(k) Number K180437
Device Name Hexanium® TLIF
Applicant
SpineVision, SAS
10 Rue de la Renaissance, Batiment E
Antony,  FR 92160
Applicant Contact Anaella Gallego
Correspondent
Orgenix LLC
111 Hill Road
Douglassville,  PA  19518
Correspondent Contact Donald W Guthner
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/20/2018
Decision Date 05/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-