Bionx Implants, Inc. is one of 33 FDA 510(k) medical device manufacturers from Finland in the dataset, ranked by real submission volume.
Bionx Implants, Inc. - FDA 510(k) Cleared Devices
Recent clearances: NUGEN FX SCREW, BIOSORBFX O/M 2.0/2/4 SYSTEM, MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
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
Cleared
Oct 04, 2002
NUGEN FX SCREW
Orthopedic
23d
Cleared
Feb 22, 2002
BIOSORBFX O/M 2.0/2/4 SYSTEM
Dental
277d
Cleared
Nov 21, 2001
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
Orthopedic
28d
Cleared
Oct 12, 2001
BIOCUFF,C, MODELS 236018, 236028, 236036
Orthopedic
30d
Cleared
Sep 19, 2001
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
Orthopedic
57d
Cleared
Jun 13, 2001
PLLA PIN
Orthopedic
72d
Cleared
May 25, 2001
MENISCUS ARROW SHEATH #CN1000A
Orthopedic
88d
Cleared
Mar 14, 2001
BIOSORBFX AND BIOSORBPDX MESH
Dental
6d
Cleared
Feb 20, 2001
PLGA PIN, MODEL...
Orthopedic
84d
Cleared
Jan 12, 2001
CONTOUR LABRAL NAIL, MODEL 533520A
Orthopedic
21d
Cleared
Jan 03, 2001
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH...
Dental
28d
Cleared
Jul 28, 2000
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
Orthopedic
88d