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, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
510(k) Number K100048
Device Name E1 ANTIOXIDANT INFUSED TECHNOLOGY
Applicant
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact BECKY EARL
Correspondent
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact BECKY EARL
Regulation Number888.3560
Classification Product Code
OIY  
Subsequent Product Codes
JDI   JWH   LPH   LWJ   LZO  
MAY   OQG   OQH   OQI  
Date Received01/08/2010
Decision Date 03/09/2010
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
-
-