• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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, cervical
510(k) Number K130306
Device Name INCITE ANCHORED CERVICAL INTERBODY DEVICE
Original Applicant
INCITE INNOVATION LLC
1500 main street
ste. 2410
springfield,  MA  01115
Original Contact john kirwan
Regulation Number888.3080
Classification Product Code
OVE  
Date Received02/07/2013
Decision Date 04/11/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-