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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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ASCENT LE - 18257200018857

3.5MM X 20MM SMOOTH SHANK SCREW, ASCENT LE POCT
Orthofix US LLC
66-3120
In Commercial Distribution

  • 18257200018857 ()


  • Bone-screw internal spinal fixation system, non-sterile

ASCENT LE - 18257200018840

3.5MM X 18MM SMOOTH SHANK SCREW, ASCENT LE POCT
Orthofix US LLC
66-3118
In Commercial Distribution

  • 18257200018840 ()


  • Bone-screw internal spinal fixation system, non-sterile

CONSTRUX - MINI PEEK VBR;CONSTRUX - MINI PTC - 18257200134137

IMPLANT CADDY, 15MM W X 12MM D, LORDOTIC (47-9116)
Orthofix US LLC
450685-0001
In Commercial Distribution

  • 18257200134137 ()


  • Metallic spinal interbody fusion cage

CONSTRUX - MINI PEEK VBR;CONSTRUX - MINI PTC - 18257200134120

IMPLANT CADDY, 12MM W X 12MM D, LORDOTIC (47-9115)
Orthofix US LLC
450684-0001
In Commercial Distribution

  • 18257200134120 ()


  • Metallic spinal interbody fusion cage

CONSTRUX - MINI PEEK VBR;CONSTRUX - MINI PTC - 18257200134113

IMPLANT CADDY, 15MM W X 12MM D, PARALLEL (47-9114)
Orthofix US LLC
450683-0001
In Commercial Distribution

  • 18257200134113 ()


  • Metallic spinal interbody fusion cage

CONSTRUX - MINI PEEK VBR;CONSTRUX - MINI PTC - 18257200134106

IMPLANT CADDY, 12MM W X 12MM D, PARALLEL (47-9113)
Orthofix US LLC
450682-0001
In Commercial Distribution

  • 18257200134106 ()


  • Metallic spinal interbody fusion cage

LONESTAR - 18257200090440

DIA 4.0MM X 18MM RESCUE BONE SCREW - SELF TAPPING
Orthofix US LLC
83-3918
In Commercial Distribution

  • 18257200090440 ()


  • Metallic spinal interbody fusion cage

LONESTAR - 18257200090433

DIA 4.0MM X 16MM RESCUE BONE SCREW - SELF TAPPING
Orthofix US LLC
83-3916
In Commercial Distribution

  • 18257200090433 ()


  • Metallic spinal interbody fusion cage

LONESTAR - 18257200090426

DIA 4.0MM X 14MM RESCUE BONE SCREW - SELF TAPPING
Orthofix US LLC
83-3914
In Commercial Distribution

  • 18257200090426 ()


  • Metallic spinal interbody fusion cage

LONESTAR - 18257200090419

DIA 4.0MM X 12MM RESCUE BONE SCREW - SELF TAPPING
Orthofix US LLC
83-3912
In Commercial Distribution

  • 18257200090419 ()


  • Metallic spinal interbody fusion cage
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