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 integrated fixation, lumbar
510(k) Number K112700
Device Name FRONTIER SADL INTERBODY FUSION DEVICE
Applicant
FRONTIER MEDICAL DEVICES, INC.
13540 GUILD AVENUE
APPLE VALLEY,  MN  55124
Applicant Contact RICH JANSEN
Correspondent
FRONTIER MEDICAL DEVICES, INC.
13540 GUILD AVENUE
APPLE VALLEY,  MN  55124
Correspondent Contact RICH JANSEN
Regulation Number888.3080
Classification Product Code
OVD  
Date Received09/16/2011
Decision Date 11/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-