Medical Device Manufacturer · FI , Tampere

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

18 submissions · 18 cleared · Since 1998
18
Total
18
Cleared
0
Denied

Bionx Implants, Inc. has 18 FDA 510(k) cleared medical devices. Based in Tampere, FI.

Historical record: 18 cleared submissions from 1998 to 2002. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Bionx Implants, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Bionx Implants, Inc.
18 devices
1-18 of 18
Cleared Oct 04, 2002
NUGEN FX SCREW
K023022 · HWC
Orthopedic · 23d
Cleared Feb 22, 2002
BIOSORBFX O/M 2.0/2/4 SYSTEM
K011569 · JEY
Dental · 277d
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 Mar 14, 2001
BIOSORBFX AND BIOSORBPDX MESH
K010687 · JEY
Dental · 6d
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 Jan 03, 2001
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH...
K003756 · JEY
Dental · 28d
Cleared Jul 28, 2000
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
K001378 · MAI
Orthopedic · 88d
Cleared Jun 08, 2000
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
K000836 · JEY
Dental · 86d
Cleared Feb 17, 1999
BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM
K982721 · JEY
Dental · 197d
Cleared Sep 15, 1998
BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM
K982139 · JEY
Dental · 90d
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
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