Spinecraft, Inc.

17 devices* 20 registrations
✕ UK (MHRA) ✕ EU (EUDAMED) ✕ Canada (Health Canada)
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Devices

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Device Name US UK CA AU EU
ALTUM ANTERIOR CERVICAL PLATE 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)
ANTERIS Thoracolumbar 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)
APEX-DL Spine 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)
APEX SPINE 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)
APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER 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)
APEX SPINE SYSTEM W/ COCR RODS 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)
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments 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)
ASTRA-OCT Spine System Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
ASTRA SPINE SYSTEM Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
ORIO-3D Cage 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)
ORIO Cage System Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES 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)
ORIO Ti Cage System Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
ORIO-Ti Intervertebral Body Fusion Cage 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)
OSTEOPORE TCP 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)
VELOX ACP Spine System Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Registered with AU (TGA) Not registered with EU (EUDAMED)
VELOX 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)

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