• 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 integrated fixation, lumbar
510(k) Number K191263
Device Name Idys ALIF TiVac
Clariance SAS
18 rue Robespierre
beaurains,  FR 62217
Applicant Contact fadwa bahr
Hogan Lovells US LLP
1735 Market Street, Suite 2300
philadelphia,  PA  19103
Correspondent Contact janice m. hogan
Regulation Number888.3080
Classification Product Code
Date Received05/10/2019
Decision Date 06/06/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No