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 Spinal Vertebral Body Replacement Device
510(k) Number K112429
Device Name GIZA(R) VERTEBRAL BODY REPLACEMENT
Applicant
Eden Spine, LLC
13540 Guild Ave.
Apple Valley,  MN  55124
Applicant Contact RICH JANSEN
Correspondent
Eden Spine, LLC
13540 Guild Ave.
Apple Valley,  MN  55124
Correspondent Contact RICH JANSEN
Regulation Number888.3060
Classification Product Code
MQP  
Date Received08/23/2011
Decision Date 01/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-