• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name filler, bone void, calcium compound
510(k) Number K042911
Device Name CEMENTEK LV
Original Applicant
TEKNIMED SA
1001 oakwood blvd
round rock,  TX  78681
Original Contact j.d. webb
Regulation Number888.3045
Classification Product Code
MQV  
Date Received10/21/2004
Decision Date 12/27/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-