• 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 intervertebral fusion device with integrated fixation, lumbar
510(k) Number K161379
Device Name ELSA Spacers
Applicant
GLOBUS MEDICAL, INC.
2560 general armistead ave.
audubon,  PA  19403
Applicant Contact kelly j. baker
Correspondent
GLOBUS MEDICAL, INC.
2560 general armistead ave.
audubon,  PA  19403
Correspondent Contact kelly j. baker
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received05/18/2016
Decision Date 09/29/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-