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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 Size Type Device Class Implantable

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The SmartBone is a 3D-printed, patient-specific device that is used to set the Glenoid Intelligent Reusable Instrument (IRI) at the time of surgery. This bone model is a 1-to-1 representation of a specific patient's bony anatomy. The SmartBone is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
A
Not in Commercial Distribution

  • 00811813020235 ()

  • Patient-specific
0006-0007-UPI

  • Orthopaedic prosthesis implantation positioning instrument, single-use
Poly Screw B type (Double) 8.0 x 50mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319783299 ()

  • Length: 50 Millimeter
  • Diameter 8.0mm
FX.PD.8050

  • Bone-screw internal spinal fixation system, non-sterile
Poly Screw B type (Double) 8.0 x 45mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319783282 ()

  • Length: 45 Millimeter
  • Diameter 8.0mm
FX.PD.8045

  • Bone-screw internal spinal fixation system, non-sterile
Poly Screw B type (Double) 8.0 x 40mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319783275 ()

  • Diameter 8.0mm
  • Length: 40 Millimeter
FX.PD.8040

  • Bone-screw internal spinal fixation system, non-sterile
Poly Screw B type (Double) 8.0 x 35mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319783268 ()

  • Diameter 8.0mm
  • Length: 35 Millimeter
FX.PD.8035

  • Bone-screw internal spinal fixation system, non-sterile
Poly Screw B type (Double) 8.0 x 30mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319783251 ()

  • Length: 30 Millimeter
  • Diameter 8.0mm
FX.PD.8030

  • Bone-screw internal spinal fixation system, non-sterile
Poly Screw B type (Double) 8.0 x 25mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319783244 ()

  • Diameter 8.0mm
  • Length: 25 Millimeter
FX.PD.8025

  • Bone-screw internal spinal fixation system, non-sterile
Poly Screw B type (Double) 7.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319783237 ()

  • Length: 90 Millimeter
  • Diameter 7.5mm
FX.PD.7590

  • Bone-screw internal spinal fixation system, non-sterile
Poly Screw B type (Double) 7.5 x 85mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319783220 ()

  • Diameter 7.5mm
  • Length: 85 Millimeter
FX.PD.7585

  • Bone-screw internal spinal fixation system, non-sterile
Poly Screw B type (Double) 7.5 x 80mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319783213 ()

  • Diameter 7.5mm
  • Length: 80 Millimeter
FX.PD.7580

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