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 Cement, Bone, Vertebroplasty
510(k) Number K080873
Device Name OPACITY + BONE CEMENT
Applicant
Teknimed, S.A.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Applicant Contact J.D. WEBB
Correspondent
Teknimed, S.A.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J.D. WEBB
Regulation Number888.3027
Classification Product Code
NDN  
Date Received03/31/2008
Decision Date 08/28/2008
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
-
-