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Bionx Implants, Inc.

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K023022 NUGEN FX SCREWHWC2002-10-04 View
510(k) K011569 BIOSORBFX O/M 2.0/2/4 SYSTEMJEY2002-02-22 View
510(k) K013546 MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214HWC2001-11-21 View
510(k) K013057 BIOCUFF,C, MODELS 236018, 236028, 236036MAI2001-10-12 View
510(k) K012334 CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116MAI2001-09-19 View
510(k) K010983 PLLA PINHTY2001-06-13 View
510(k) K010554 MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000AHWC2001-05-25 View
510(k) K010687 BIOSORBFX AND BIOSORBPDX MESHJEY2001-03-14 View
510(k) K003659 PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260HTY2001-02-20 View
510(k) K003970 CONTOUR LABRAL NAIL, MODEL 533520AMAI2001-01-12 View
510(k) K003756 BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATESJEY2001-01-03 View
510(k) K001378 BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736MAI2000-07-28 View
510(k) K000836 BIOSORBPDX BIOABSORBABLE FIXATION SYSTEMJEY2000-06-08 View
510(k) K982721 BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEMJEY1999-02-17 View
510(k) K982139 BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEMJEY1998-09-15 View
510(k) K972783 BIOFIX BIODEGRADABLE THREADED SUTURE ANCHORMAI1998-04-14 View
510(k) K972919 BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREWHWC1998-03-27 View
510(k) K974876 BIONX DISTAL RADIUS SCREWMAI1998-03-20 View
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