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 K143377
Device Name PedFuse Pedicle Screw System
Applicant
SPINEFRONTIER, INC.
500 CUMMINGS CENTER
SUITE 3500
BEVERLY,  MA  01915
Applicant Contact Manthan J Damani
Correspondent
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Kenneth C Maxwell
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received11/25/2014
Decision Date 02/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-