FDA 510(k) Applications Submitted by BIONX IMPLANTS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K003756 |
12/06/2000 |
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES |
BIONX IMPLANTS, INC. |
| K023022 |
09/11/2002 |
NUGEN FX SCREW |
BIONX IMPLANTS, INC. |
| K982139 |
06/17/1998 |
BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM |
BIONX IMPLANTS, INC. |
| K972783 |
07/25/1997 |
BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR |
BIONX IMPLANTS, INC. |
| K982721 |
08/04/1998 |
BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM |
BIONX IMPLANTS, INC. |
| K972919 |
08/07/1997 |
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW |
BIONX IMPLANTS, INC. |
| K974876 |
12/29/1997 |
BIONX DISTAL RADIUS SCREW |
BIONX IMPLANTS, INC. |
| K010554 |
02/26/2001 |
MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A |
BIONX IMPLANTS, INC. |
| K010687 |
03/08/2001 |
BIOSORBFX AND BIOSORBPDX MESH |
BIONX IMPLANTS, INC. |
| K000836 |
03/14/2000 |
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM |
BIONX IMPLANTS, INC. |
| K010983 |
04/02/2001 |
PLLA PIN |
BIONX IMPLANTS, INC. |
| K001378 |
05/01/2000 |
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 |
BIONX IMPLANTS, INC. |
| K011569 |
05/21/2001 |
BIOSORBFX O/M 2.0/2/4 SYSTEM |
BIONX IMPLANTS, INC. |
| K012334 |
07/24/2001 |
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 |
BIONX IMPLANTS, INC. |
| K013057 |
09/12/2001 |
BIOCUFF,C, MODELS 236018, 236028, 236036 |
BIONX IMPLANTS, INC. |
| K013546 |
10/24/2001 |
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 |
BIONX IMPLANTS, INC. |
| K003659 |
11/28/2000 |
PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 |
BIONX IMPLANTS, INC. |
| K003970 |
12/22/2000 |
CONTOUR LABRAL NAIL, MODEL 533520A |
BIONX IMPLANTS, INC. |
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