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, semi-constrained, metal/polymer, porous uncemented
510(k) Number K143009
Device Name Echo Bi-Metric Microplasty Hip System
Applicant
BIOMET, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Applicant Contact Julie Gantenberg, M.S.,RAC
Correspondent
BIOMET, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Correspondent Contact Julie Gantenberg, M.S.,RAC
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LWJ  
LZO   OQG   OQH   OQI   PBI  
Date Received10/20/2014
Decision Date 12/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-