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 Screw, Fixation, Bone
510(k) Number K141401
Device Name EASY OUT
Applicant
Feet For Life Podiatry Center
8637 Delmar Blvd.
St. Louis,  MO  63124
Applicant Contact MICHAEL HORWITZ
Correspondent
Emergo Group
816 Congress Ave. Suite 1400
Austin,  TX  78701
Correspondent Contact Carrie Hetrick
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/28/2014
Decision Date 02/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-