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, femoral component, cemented, metal
510(k) Number K942028
Device Name RX90 FEMORAL COMPONENT
Applicant
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA S BERES
Correspondent
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA S BERES
Regulation Number888.3360
Classification Product Code
JDG  
Date Received04/26/1994
Decision Date 09/19/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-