• 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 cerclage, fixation
510(k) Number K120177
Device Name SPINAL ELEMENTS CERCLAGE SYSTEM
Original Applicant
SPINAL ELEMENTS, INC.
2744 loker ave. w. suite 100
carlsbad,  CA  92008
Original Contact benjamin a kimball
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received01/20/2012
Decision Date 07/03/2012
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
-
-