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 K171425
Device Name CONCORDE LIFT
Applicant
Medos International, SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Karen Sylvia
Correspondent
Depuy Synthes
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Desiree Saracino
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/15/2017
Decision Date 07/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-