• 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 bone graft, lumbar
510(k) Number K150321
Device Name EVOS Lumbar Interbody System
Applicant
Cutting Edge Spine, LLC
101 waxhaw professional park, suite a
waxhaw,  NC  28173
Applicant Contact john souza
Correspondent
Cutting Edge Spine, LLC
101 waxhaw professional park drive, suite a
waxhaw,  NC  28173
Correspodent Contact john souza
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/09/2015
Decision Date 07/13/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-