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, Toe, Constrained, Polymer
510(k) Number K994326
Device Name ASCENT KNEE SYSTEM
Applicant
BIOMET MANUFACTURING, INC.
AIRPORT INDUSTRIAL PARK
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact TRACY J BICKEL
Correspondent
BIOMET MANUFACTURING, INC.
AIRPORT INDUSTRIAL PARK
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact TRACY J BICKEL
Regulation Number888.3720
Classification Product Code
KWH  
Date Received12/22/1999
Decision Date 01/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-