• 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 posterior metal/polymer spinal system, fusion
510(k) Number K061774
Device Name NFIX II PEDICLE SCREW SYSTEM
Original Applicant
N SPINE, INC.
13221 maricotte place
san diego,  CA  92130
Original Contact r. stephen reitzler
Regulation Number888.3070
Classification Product Code
NQP  
Date Received06/23/2006
Decision Date 12/13/2006
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
Recalls CDRH Recalls
-
-