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 K220131
FOIA Releasable 510(k) K220131
Device Name KYPHON VuE Bone Cement
Applicant
Tecres S.P.A.
Via Andrea Doria 6
Sommacampagna,  IT 37066
Applicant Contact Massio Grazioli
Correspondent
Brauer Device Consultants, LLC
7 Trail House Court
Rockville,  MD  20850
Correspondent Contact Christine Brauer
Regulation Number888.3027
Classification Product Code
NDN  
Date Received01/18/2022
Decision Date 04/18/2022
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
-
-