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 Thoracolumbosacral Pedicle Screw System
510(k) Number K102807
Device Name CD HORIZON SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact CHRIS MCKEE
Correspondent
Medtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact CHRIS MCKEE
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received09/28/2010
Decision Date 11/17/2010
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-