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 K112316
FOIA Releasable 510(k) K112316
Device Name 4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
Applicant
4-WEB, INC.
13540 GUILD AVE.
APPLE VALLEY,  MN  55124
Applicant Contact RICH JANSEN, PHARM. D.
Correspondent
4-WEB, INC.
13540 GUILD AVE.
APPLE VALLEY,  MN  55124
Correspondent Contact RICH JANSEN, PHARM. D.
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/11/2011
Decision Date 12/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-