• 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 orthosis, spinal pedicle fixation, for degenerative disc disease
510(k) Number K121103
Device Name LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S
Original Applicant
LDR SPINE USA INC.
13785 research boulevard
suite 200
austin,  TX  78750
Original Contact bradley w strasser
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MAX   MNH   MNI   MQP  
ODP   OVD   OVE  
Date Received04/11/2012
Decision Date 08/24/2012
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
-
-