• 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 | 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 orthosis, spinal pedicle fixation
510(k) Number K113755
Device Name SAVANNAH TECHNOLOGIES SPINAL SYSTEM
Original Applicant
SAVANNAH TECHNOLOGIES LLC
1001 oakwood blvd.
round rock,  TX  78681
Original Contact j.d. webb
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received12/21/2011
Decision Date 02/01/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-