• 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 K121151
Device Name PRO-LINK CERVICAL SPACER SYSTEM
Original Applicant
LIFE SPINE, INC
2401 w. hassell rd suite 1535
hoffman estates,  IL  60169
Original Contact randy lewis
Regulation Number888.3080
Classification Product Code
OVE  
Date Received04/16/2012
Decision Date 11/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-