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 K051781
Device Name GRAFTCAGE TLX
Applicant
OSTEOTECH, INC.
51 JAMES WAY
EATONTOWN,  NJ  07724
Applicant Contact CHRISTOPHER TALBOT
Correspondent
OSTEOTECH, INC.
51 JAMES WAY
EATONTOWN,  NJ  07724
Correspondent Contact CHRISTOPHER TALBOT
Regulation Number888.3060
Classification Product Code
MQP  
Date Received07/01/2005
Decision Date 12/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-