FDA 510(k) Applications Submitted by LINVATEC BIOMATERIALS, LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K031981 06/26/2003 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 LINVATEC BIOMATERIALS, LTD.
K032447 08/08/2003 CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED LINVATEC BIOMATERIALS, LTD.
K042295 08/24/2004 SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 LINVATEC BIOMATERIALS, LTD.
K042517 09/15/2004 BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS LINVATEC BIOMATERIALS, LTD.
K042966 10/28/2004 DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H LINVATEC BIOMATERIALS, LTD.


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