ORTHOFIX US LLC

20 devices* 32 registrations
✕ UK (MHRA) ✕ EU (EUDAMED)
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Devices

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Device Name US UK CA AU EU
3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
AccelStim™ Registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
CERVICAL-STIM Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
CONTOURS VPS - BONE PLATE Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
CONTOURS VPS - CORTICAL SCREWS NON-LOCKING Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
CONTOURS VPS - INSTRUMENTS Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
CONTOURS VPS - KIT Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
CONTOURS VPS - LOCKING PARTIAL MICRO THREAD SCREWS Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
CONTOURS VPS - LOCKING PARTIAL THREADED SCREWS Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
CONTOURS VPS - NON-LOCKING, FULL THREAD SCREWS Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Firebird SI Navigation System Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
FORZA XP Expandable Spacer System Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
ISKD INTERNAL LIMB LENGHTENER - FEMORAL Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
ISKD INTERNAL LIMB LENGTHENER TIBIAL Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
ISKD LOCKING SCREWS Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
ISKD REVISION LOCKING SCREWS Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
OFIX MIS App Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
PHYSIO-STIM Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
REPLACEMENT AQUASONICS 100 ULTRASOUND GEL Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
SPINAL-STIM Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
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