Medical Device Manufacturer · US , Mckinney , TX

Orthofix, Inc. - FDA 510(k) Cleared Devices

57 submissions · 57 cleared · Since 1996

57

Total

57

Cleared

0

Denied

57 devices

51-57 of 57

Cleared Sep 27, 2010

CONSTRUX MINI PEEK SPACER SYSTEM

Orthopedic · 90d

Cleared Jun 10, 2010

GUIDED GROWTH SYSTEM

Orthopedic · 217d

Cleared Nov 16, 2004

ORTHOFIX VOLAR DISTAL RADIAL PLATE

Orthopedic · 42d

Cleared May 28, 2003

MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)

Orthopedic · 41d

Cleared May 02, 1997

BONE SOURCE HYDROXYAPATITE

General & Plastic Surgery · 88d

Cleared May 08, 1996

ORTHOFIX TIBIAL NAILING SYSTEM

Orthopedic · 55d

Cleared Mar 20, 1996

ORTHOFIX MODULSYSTEM

Orthopedic · 84d