• 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 plate, fixation, bone
510(k) Number K160995
Device Name NEOVIEW Plating System
Applicant
In2Bones SAS
28 Chemin du Petit Bois
ecully,  FR 69130
Applicant Contact morgane grenier
Correspondent
Estrin Consulting Group LLC
9109 Copenhaver Drive
potomac,  MD  20854
Correspondent Contact norman f estrin
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/08/2016
Decision Date 06/10/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-