• 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 K031826
Device Name TRIHA +
Original Applicant
TEKNIMED SA
1001 oakwood blvd
roundrock,  TX  78681
Original Contact j. d webb
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/13/2003
Decision Date 11/28/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-