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 Appliance, Fixation, Spinal Interlaminal
510(k) Number K131833
Device Name CENTURION POCT SYSTEM
Applicant
Orthofix, Inc.
3451 Plano Pkwy.
Lweisville,  TX  75056
Applicant Contact JACKI GEREN
Correspondent
Orthofix, Inc.
3451 Plano Pkwy.
Lweisville,  TX  75056
Correspondent Contact JACKI GEREN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received06/20/2013
Decision Date 01/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-