• 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 stimulator, spinal-cord, implanted (pain relief)
510(k) Number K112849
Model FB-101-01
Device Name FIXATE TISSUE BAND
Original Applicant
ANULEX TECHNOLOGIES, INC
5600 rowland road, ste 280
minnetonka,  MN  55343
Original Contact rachel kennedy
Regulation Number882.5880
Classification Product Code
GZB  
Subsequent Product Code
GAT  
Date Received09/29/2011
Decision Date 10/27/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-