• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name prosthesis, hip, femoral component, cemented, metal
510(k) Number K942027
Device Name IMPACT CO-CR 1-PIECE FEMORAL COMPONENT
Original Applicant
BIOMET, INC.
p.o. box 587
warsaw,  IN  46581 -0587
Original Contact patricia beres
Regulation Number888.3360
Classification Product Code
JDG  
Date Received04/26/1994
Decision Date 09/19/1994
Decision (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-