Medical Device Manufacturer · FI , Tampere

Bionx Implants, Ltd. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1999

Recent clearances: SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525, SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030, MENISCUS ARROW, MODELS 531110, 531113, 531116

12

Total

12

Cleared

0

Denied

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

11 devices

1-11 of 11

Cleared Apr 24, 2003

IMPACT SUTURE ANCHOR. MODEL 433510

Orthopedic · 78d

Cleared Jun 26, 2002

DUET SUTURE ANCHOR

Orthopedic · 169d

Cleared Jul 18, 2001

1.5MM BONE FIXATION KIT

Orthopedic · 21d

Cleared Jul 18, 2001

Orthopedic · 21d

Cleared Apr 26, 2001

SMARTSCREW MODEL 222006...227510

Orthopedic · 205d

Cleared Mar 23, 2000

SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828

Orthopedic · 28d

Cleared Dec 10, 1999

SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525

Orthopedic · 87d

Cleared Dec 06, 1999

SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030,...

Orthopedic · 83d

Cleared Nov 09, 1999

MENISCUS ARROW, MODELS 531110, 531113, 531116

Orthopedic · 27d

Cleared Sep 21, 1999

CANNULATED SMARTSCREW MODELS 224540C, 224570C

Orthopedic · 20d

Cleared Aug 27, 1999

ANATOMICAL BANKART TACK, MODEL 523520A

Orthopedic · 25d