• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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
Applicant
N SPINE, INC.
13221 maricotte place
san diego,  CA  92130
Applicant Contact r. stephen reitzler
Correspondent
N SPINE, INC.
13221 maricotte place
san diego,  CA  92130
Correspodent Contact r. stephen reitzler
Regulation Number888.3070
Classification Product Code
NQP  
Date Received06/23/2006
Decision Date 12/13/2006
Decision se - with limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
-
-