• 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, patello/femoral, semi-constrained, cemented, metal/polymer
510(k) Number K143543
Device Name Prelude PF Patellae
Applicant
BIOMET INC.
56 EAST BELL DRIVE
warsaw,  IN  46581
Applicant Contact jared cooper
Correspondent
BIOMET INC.
56 EAST BELL DRIVE
warsaw,  IN  46581
Correspondent Contact jared cooper
Regulation Number888.3540
Classification Product Code
KRR  
Date Received12/15/2014
Decision Date 01/30/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-