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, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
510(k) Number K042841
FOIA Releasable 510(k) K042841
Device Name M2A/C2A ACETABULAR SYSTEM
Applicant
Biomet, Inc.
56 E. Bell Dr.
P.O. Box 587
Warsaw,  IN  46582
Applicant Contact PATRICIA S ANDBORN BERES
Correspondent
Biomet, Inc.
56 E. Bell Dr.
P.O. Box 587
Warsaw,  IN  46582
Correspondent Contact PATRICIA S ANDBORN BERES
Regulation Number888.3320
Classification Product Code
JDL  
Subsequent Product Code
KWA  
Date Received10/14/2004
Decision Date 12/21/2004
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
-
-