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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K994366
Device Name TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
Applicant
HOWMEDICA OSTEONICS CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070 -2584
Applicant Contact NANCY J RIEDER
Correspondent
HOWMEDICA OSTEONICS CORP.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070 -2584
Correspondent Contact NANCY J RIEDER
Regulation Number888.3353
Classification Product Code
MEH  
Date Received12/27/1999
Decision Date 03/16/2000
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
-
-