• 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
 


New Search Back To Search Results
Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K091502
Device Name NUVASIVE SPHERX II SYSTEM
Applicant
NUVASIVE, INC.
7475 LUSK BLVD
san diego,  CA  92121
Applicant Contact han fan
Correspondent
NUVASIVE, INC.
7475 LUSK BLVD
san diego,  CA  92121
Correspondent Contact han fan
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received05/21/2009
Decision Date 07/22/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-