Medical Device Manufacturer · US , Rockville , MD

Orthofix Srl - FDA 510(k) Cleared Devices

38 submissions · 38 cleared · Since 1995

38

Total

38

Cleared

0

Denied

38 devices

26-38 of 38

Cleared Dec 10, 2014

Orthofix True Lok Hexapod System VI.3

Orthopedic · 40d

Cleared Dec 08, 2014

ORTHOFIX GALAXY WRIST

Orthopedic · 160d

Cleared Dec 05, 2014

ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT

Orthopedic · 130d

Cleared Nov 12, 2014

ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM

Orthopedic · 153d

Cleared Sep 02, 2014

ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)

Orthopedic · 130d

Cleared Sep 20, 2012

ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)

Orthopedic · 30d

Cleared Sep 04, 2012

ORTHOFIX GALAXY FIXATION SYSTEM

Orthopedic · 257d

Cleared Nov 13, 2006

ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP

Orthopedic · 46d

Cleared Dec 12, 2005

ORTHOFIX TITANIUM NAILING SYSTEMS

Orthopedic · 20d

Cleared Sep 06, 2005

MIOT PLATING SYSTEM

Orthopedic · 50d

Cleared Mar 18, 1998

ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING

Orthopedic · 131d

Cleared Dec 19, 1997

ORTHOFIX FEMORAL NAILING SYTEM

Orthopedic · 64d

Cleared Apr 04, 1995

ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM

Orthopedic · 225d