Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 orthosis, spondylolisthesis spinal fixation
510(k) Number K120760
Device Name LDR SPINE SPINETUNE TL SPINAL SYSTEM
Applicant
LDR SPINE USA INC.
13785 RESEARCH BOULEVARD
SUITE 200
AUSTIN,  TX  78750
Applicant Contact KIERSTEN SODERMAN
Correspondent
LDR SPINE USA INC.
13785 RESEARCH BOULEVARD
SUITE 200
AUSTIN,  TX  78750
Correspondent Contact KIERSTEN SODERMAN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received03/13/2012
Decision Date 06/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-