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 K023835
Device Name DEVEX MESH SYSTEM
Applicant
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact KAREN F JURCZAK
Correspondent
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact KAREN F JURCZAK
Regulation Number888.3060
Classification Product Code
MQP  
Date Received11/18/2002
Decision Date 01/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-