• 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 bone graft, lumbar
510(k) Number K121129
Device Name SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
Original Applicant
SPINEOLOGY, INC.
7800 3rd st n., suite 600
st. paul,  MN  55128
Original Contact bryan becker
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/13/2012
Decision Date 06/13/2012
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
-
-