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 posterior metal/polymer spinal system, fusion
510(k) Number K073347
Device Name DYNESYS TOP-LOADING SPINAL SYSTEM
Applicant
ZIMMER SPINE, INC
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2027
Applicant Contact ELSA A LINKE
Correspondent
ZIMMER SPINE, INC
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2027
Correspondent Contact Elsa A Linke
Regulation Number888.3070
Classification Product Code
NQP  
Date Received11/29/2007
Decision Date 02/08/2008
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-