Medical Device Manufacturer · FI , Tampere

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

12 submissions · 12 cleared · Since 1999

Recent clearances: IMPACT SUTURE ANCHOR. MODEL 433510, DUET SUTURE ANCHOR, 1.5MM BONE FIXATION KIT

View 12 510(k) Devices ↓

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