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 Cement, Bone, Vertebroplasty
510(k) Number K072133
Device Name AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
Applicant
Cardinal Health, Inc.
1430 Waukegan Rd.- Mpkb-3b
Mcgaw Park,  IL  60085
Applicant Contact SHARON NICHOLS
Correspondent
Cardinal Health, Inc.
1430 Waukegan Rd.- Mpkb-3b
Mcgaw Park,  IL  60085
Correspondent Contact SHARON NICHOLS
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Codes
HXG   OAR  
Date Received08/02/2007
Decision Date 11/20/2007
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
-
-