Bionx Implants, Ltd. is one of 38 FDA 510(k) medical device manufacturers from Finland in the dataset, ranked by real submission volume.
Bionx Implants, Ltd. - FDA 510(k) Cleared Devices
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
Bionx Implants, Ltd. has 12 FDA 510(k) cleared orthopedic devices. Based in Tampere, FI.
Historical record: 12 cleared submissions from 1999 to 2003.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Bionx Implants, Ltd.
12 devices
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
SMARTSCREW
Orthopedic
21d
Cleared
Apr 26, 2001
SMARTSCREW MODEL 222006...227510
Orthopedic
205d
Cleared
Feb 07, 2001
THERMOFX MESH
Dental
63d
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