FDA 510(k) Applications Submitted by TUIJA ANNALA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020056 |
01/08/2002 |
DUET SUTURE ANCHOR |
BIONX IMPLANTS, LTD. |
| K030388 |
02/05/2003 |
IMPACT SUTURE ANCHOR. MODEL 433510 |
BIONX IMPLANTS, LTD. |
| K000616 |
02/24/2000 |
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 |
BIONX IMPLANTS, LTD. |
| 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. |
| K041288 |
05/13/2004 |
MODIFICATION TO SMARTPIN |
LINVATEC BIOMATERIALS, INC. |
| K011569 |
05/21/2001 |
BIOSORBFX O/M 2.0/2/4 SYSTEM |
BIONX IMPLANTS, INC. |
| K012000 |
06/27/2001 |
1.5MM BONE FIXATION KIT |
BIONX IMPLANTS, LTD. |
| K012001 |
06/27/2001 |
SMARTSCREW |
BIONX IMPLANTS, LTD. |
| K012334 |
07/24/2001 |
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 |
BIONX IMPLANTS, INC. |
| K992567 |
08/02/1999 |
ANATOMICAL BANKART TACK, MODEL 523520A |
BIONX IMPLANTS, LTD. |
| K052080 |
08/02/2005 |
MATRYX INTERFERENCE SCREW |
LINVATEC BIOMATERIALS, INC. |
| K032447 |
08/08/2003 |
CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED |
LINVATEC BIOMATERIALS, LTD. |
| K042295 |
08/24/2004 |
SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 |
LINVATEC BIOMATERIALS, LTD. |
| K992947 |
09/01/1999 |
CANNULATED SMARTSCREW MODELS 224540C, 224570C |
BIONX IMPLANTS, LTD. |
| K013057 |
09/12/2001 |
BIOCUFF,C, MODELS 236018, 236028, 236036 |
BIONX IMPLANTS, INC. |
| K993073 |
09/14/1999 |
SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 |
BIONX IMPLANTS, LTD. |
| K993074 |
09/14/1999 |
SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 |
BIONX IMPLANTS, LTD. |
| K042517 |
09/15/2004 |
BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS |
LINVATEC BIOMATERIALS, LTD. |
| K032894 |
09/17/2003 |
OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, |
LINVATEC BIOMATERIALS, INC. |
| K993453 |
10/13/1999 |
MENISCUS ARROW, MODELS 531110, 531113, 531116 |
BIONX IMPLANTS, LTD. |
| K013546 |
10/24/2001 |
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 |
BIONX IMPLANTS, INC. |
| K042966 |
10/28/2004 |
DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H |
LINVATEC BIOMATERIALS, LTD. |
| K003659 |
11/28/2000 |
PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 |
BIONX IMPLANTS, INC. |
| K003757 |
12/06/2000 |
THERMOFX MESH |
BIONX IMPLANTS, LTD. |
| K003970 |
12/22/2000 |
CONTOUR LABRAL NAIL, MODEL 533520A |
BIONX IMPLANTS, INC. |
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