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 shoulder prosthesis, reverse configuration
510(k) Number K211729
Device Name Comprehensive® Convertible Glenoid - Vivacit-E Liner
Applicant
Biomet Manufacturing Corp.
56 East Bell Drive
Warsaw,  IN  46582
Applicant Contact Patricia Sandborn Beres
Correspondent
Biomet Manufacturing Corp.
56 East Bell Drive
Warsaw,  IN  46582
Correspondent Contact Patricia Sandborn Beres
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   KWT   MBF   PAO  
Date Received06/04/2021
Decision Date 11/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-