FDA 510(k) Applications Submitted by BIONX IMPLANTS, LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K003077 |
10/03/2000 |
SMARTSCREW MODEL 222006...227510 |
BIONX IMPLANTS, LTD. |
| 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. |
| K012000 |
06/27/2001 |
1.5MM BONE FIXATION KIT |
BIONX IMPLANTS, LTD. |
| K012001 |
06/27/2001 |
SMARTSCREW |
BIONX IMPLANTS, LTD. |
| K992567 |
08/02/1999 |
ANATOMICAL BANKART TACK, MODEL 523520A |
BIONX IMPLANTS, LTD. |
| K992947 |
09/01/1999 |
CANNULATED SMARTSCREW MODELS 224540C, 224570C |
BIONX IMPLANTS, LTD. |
| 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. |
| K993453 |
10/13/1999 |
MENISCUS ARROW, MODELS 531110, 531113, 531116 |
BIONX IMPLANTS, LTD. |
| K003757 |
12/06/2000 |
THERMOFX MESH |
BIONX IMPLANTS, LTD. |
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