Company ยท FI
Bionx Implants, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2003. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2003 | K030388 | IMPACT SUTURE ANCHOR. MODEL 433510 Bionx Implants, Ltd., FI | HWC |
| Oct 4, 2002 | K023022 | NUGEN FX SCREW Bionx Implants, Inc. | HWC |
| Jun 26, 2002 | K020056 | DUET SUTURE ANCHOR Bionx Implants, Ltd., FI | HWC |
| Feb 22, 2002 | K011569 | BIOSORBFX O/M 2.0/2/4 SYSTEM Bionx Implants, Inc., FI | JEY |
| Nov 21, 2001 | K013546 | MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 Bionx Implants, Inc., FI | HWC |
| Oct 12, 2001 | K013057 | BIOCUFF,C, MODELS 236018, 236028, 236036 Bionx Implants, Inc., FI | MAI |
| Sep 19, 2001 | K012334 | CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 Bionx Implants, Inc., FI | MAI |
| Jul 18, 2001 | K012001 | SMARTSCREW Bionx Implants, Ltd., FI | HWC |
| Jul 18, 2001 | K012000 | 1.5MM BONE FIXATION KIT Bionx Implants, Ltd., FI | HWC |
| Jun 13, 2001 | K010983 | PLLA PIN Bionx Implants, Inc., FI | HTY |
| May 25, 2001 | K010554 | MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A Bionx Implants, Inc., FI | HWC |
| Apr 26, 2001 | K003077 | SMARTSCREW MODEL 222006...227510 Bionx Implants, Ltd. | HWC |
| Mar 14, 2001 | K010687 | BIOSORBFX AND BIOSORBPDX MESH Bionx Implants, Inc., FI | JEY |
| Feb 20, 2001 | K003659 | PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 Bionx Implants, Inc., FI | HTY |
| Feb 7, 2001 | K003757 | THERMOFX MESH Bionx Implants, Ltd., FI | JEY |
| Jan 12, 2001 | K003970 | CONTOUR LABRAL NAIL, MODEL 533520A Bionx Implants, Inc., FI | MAI |
| Jan 3, 2001 | K003756 | BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES Bionx Implants, Inc. | JEY |
| Jul 28, 2000 | K001378 | BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 Bionx Implants, Inc., FI | MAI |
| Jun 8, 2000 | K000836 | BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM Bionx Implants, Inc., FI | JEY |
| Mar 23, 2000 | K000616 | SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 Bionx Implants, Ltd., FI | MAI |
| Dec 10, 1999 | K993074 | SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 Bionx Implants, Ltd., FI | MAI |
| Dec 6, 1999 | K993073 | SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 Bionx Implants, Ltd., FI | MAI |
| Nov 9, 1999 | K993453 | MENISCUS ARROW, MODELS 531110, 531113, 531116 Bionx Implants, Ltd., FI | MAI |
| Sep 21, 1999 | K992947 | CANNULATED SMARTSCREW MODELS 224540C, 224570C Bionx Implants, Ltd., FI | HWC |
| Aug 27, 1999 | K992567 | ANATOMICAL BANKART TACK, MODEL 523520A Bionx Implants, Ltd., FI | MAI |
| Feb 17, 1999 | K982721 | BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM Bionx Implants, Inc. | JEY |
| Sep 15, 1998 | K982139 | BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM Bionx Implants, Inc. | JEY |
| Apr 14, 1998 | K972783 | BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR Bionx Implants, Inc. | MAI |
| Mar 27, 1998 | K972919 | BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW Bionx Implants, Inc. | HWC |
| Mar 20, 1998 | K974876 | BIONX DISTAL RADIUS SCREW Bionx Implants, Inc. | MAI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||