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 K153649
Device Name Exactech® Novation® Element Press-fit Femoral Stem
Applicant
EXACTECH INC
2320 NW 66TH COURT
GAINESVILLE,  FL  32653
Applicant Contact Thomas McNamara
Correspondent
EXACTECH INC
2320 NW 66TH COURT
GAINESVILLE,  FL  32653
Correspondent Contact Thomas McNamara
Regulation Number888.3353
Classification Product Code
MEH  
Date Received12/21/2015
Decision Date 08/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-