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 Spinal Vertebral Body Replacement Device
510(k) Number K052950
Device Name THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM
Applicant
Zimmer Trabecular
80 Commerce Dr.
Allendale,  NJ  07401
Applicant Contact MARCI HALEVI
Correspondent
Zimmer Trabecular
80 Commerce Dr.
Allendale,  NJ  07401
Correspondent Contact MARCI HALEVI
Regulation Number888.3060
Classification Product Code
MQP  
Date Received10/20/2005
Decision Date 11/16/2005
Decision Substantially Equivalent (SESE)
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
-
-