• 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
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
-
-