• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name intervertebral fusion device with integrated fixation, cervical
510(k) Number K122630
Device Name IN:C2 SPINAL FIXATION SYSTEM
Applicant
SPINE SMITH PARTNERS L.P.
93 red river
austin,  TX  78701
Applicant Contact clifton (chris) naivar
Correspondent
SPINE SMITH PARTNERS L.P.
93 red river
austin,  TX  78701
Correspodent Contact clifton (chris) naivar
Regulation Number888.3080
Classification Product Code
OVE  
Date Received08/28/2012
Decision Date 12/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-