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 K163710
Device Name BePOD® EZ Weil Screws
Applicant
Fournitures Hospitalieres Industrie
Zi De Kernevez-6 Rue Nobel
Quimper Finistere,  FR 29000
Applicant Contact Patricia Donnard
Correspondent
Fournitures Hospitalieres Industrie
6 Rue Nobel, Z.I. De Kernévez
Quimper,  FR 29000
Correspondent Contact Patricia Donnard
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/30/2016
Decision Date 09/08/2017
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
-
-