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

FDA 510(k) Regulatory Record - Bionx Implants, Inc. Orthopedic ✕

12 devices

1-12 of 12

Cleared Oct 04, 2002

Orthopedic · 23d

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

Orthopedic · 72d

Cleared May 25, 2001

MENISCUS ARROW SHEATH #CN1000A

Orthopedic · 88d

Cleared Feb 20, 2001

PLGA PIN, MODEL...

Orthopedic · 84d

Cleared Jan 12, 2001

CONTOUR LABRAL NAIL, MODEL 533520A

Orthopedic · 21d

Cleared Jul 28, 2000

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

Orthopedic · 88d

Cleared Apr 14, 1998

BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR

Orthopedic · 263d

Cleared Mar 27, 1998

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

Orthopedic · 232d

Cleared Mar 20, 1998

BIONX DISTAL RADIUS SCREW

Orthopedic · 81d