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 Orthopedic Stereotaxic Instrument
510(k) Number K200047
Device Name ExcelsiusGPS Cranial 1.0 Module
Applicant
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact Jennifer Antonacci
Correspondent
Globus Medical, Inc.
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact Jennifer Antonacci
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
HAW  
Date Received01/09/2020
Decision Date 07/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-