• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name posterior metal/polymer spinal system, fusion
510(k) Number K073439
Device Name TRANSITION STABILIZATION SYSTEM
Original Applicant
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon,  PA  19403
Original Contact kelly j baker
Regulation Number888.3070
Classification Product Code
NQP  
Date Received12/07/2007
Decision Date 02/20/2009
Decision se - with limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-