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 pedicle screw spinal system, adolescent idiopathic scoliosis
510(k) Number K153446
Device Name OLYMPIC Posterior Spinal Fixation System
Applicant
Astura Medical
5670 El Camino Real, Suite B
Carlsbad,  CA  92008
Applicant Contact Troy Taylor
Correspondent
THE ORTHOMEDIX GROUP, INC
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Correspondent Contact J.D. Webb
Regulation Number888.3070
Classification Product Code
OSH  
Subsequent Product Codes
MNH   MNI  
Date Received11/27/2015
Decision Date 04/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-