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 K071879
Device Name ZIMMER DTO IMPLANT
Applicant
ZIMMER SPINE, INC
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55441
Applicant Contact NICOLE BOWDEN
Correspondent
ZIMMER SPINE, INC
7375 Blush Lake Rd
Minneapolis,  MN  55441
Correspondent Contact Nicole Bowden
Regulation Number888.3070
Classification Product Code
NQP  
Date Received07/09/2007
Decision Date 10/05/2007
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
-
-