• 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 orthopedic stereotaxic instrument
510(k) Number K173372
Device Name ExactechGPS Total Shoulder Application
Blue Ortho
6 Allee de Bethleem
Gieres,  FR 38610
Applicant Contact Anthony Boyer
Blue Ortho
6 Allee de Bethleem
Gieres,  FR 38610
Correspondent Contact Anthony Boyer
Regulation Number882.4560
Classification Product Code
Subsequent Product Code
Date Received10/27/2017
Decision Date 11/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls