Bionx Implants, Inc. - FDA 510(k) Cleared Devices

Cleared Oct 04, 2002

NUGEN FX SCREW

K023022 · HWC

Orthopedic · 23d

Cleared Nov 21, 2001

MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214

K013546 · HWC

Orthopedic · 28d

Cleared Oct 12, 2001

BIOCUFF,C, MODELS 236018, 236028, 236036

K013057 · MAI

Orthopedic · 30d

Cleared Sep 19, 2001

CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116

K012334 · MAI

Orthopedic · 57d

Cleared Jun 13, 2001

PLLA PIN

K010983 · HTY

Orthopedic · 72d

Cleared May 25, 2001

MENISCUS ARROW SHEATH #CN1000A

K010554 · HWC

Orthopedic · 88d

Cleared Feb 20, 2001

PLGA PIN, MODEL...

K003659 · HTY

Orthopedic · 84d

Cleared Jan 12, 2001

CONTOUR LABRAL NAIL, MODEL 533520A

K003970 · MAI

Orthopedic · 21d

Cleared Jul 28, 2000

BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736

K001378 · MAI

Orthopedic · 88d

Cleared Apr 14, 1998

BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR

K972783 · MAI

Orthopedic · 263d

Cleared Mar 27, 1998

BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW

K972919 · HWC

Orthopedic · 232d

Cleared Mar 20, 1998

BIONX DISTAL RADIUS SCREW

K974876 · MAI

Orthopedic · 81d