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 Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number K030710
Device Name BIO-MODULAR SHOULDER SYSTEM
Applicant
Biomet, Inc.
56 Bell Dr.
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Biomet, Inc.
56 Bell Dr.
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
HSD   KWS   MBF  
Date Received03/06/2003
Decision Date 06/04/2003
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
Recalls CDRH Recalls
-
-