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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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A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Reconstructed Maxilla/Mandible 2-Piece Model
In Commercial Distribution

  • 00816847021104 ()


  • Custom-made organ/bone anatomy model
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Reconstructed Maxilla/Mandible 1-Piece Model
In Commercial Distribution

  • 00816847021098 ()


  • Custom-made organ/bone anatomy model
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Reconstructed Full Skull Model
In Commercial Distribution

  • 00816847021081 ()


  • Custom-made organ/bone anatomy model
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Reconstructed Mandible Model
In Commercial Distribution

  • 00816847021074 ()


  • Custom-made organ/bone anatomy model
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Reconstructed Maxilla Model
In Commercial Distribution

  • 00816847021067 ()


  • Custom-made organ/bone anatomy model
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Reconstructed Anatomical Model
In Commercial Distribution

  • 00816847021050 ()


  • Custom-made organ/bone anatomy model
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Maxilla/Mandible 2-Piece Model
In Commercial Distribution

  • 00816847021043 ()


  • Custom-made organ/bone anatomy model
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Maxilla/Mandible 1-Piece Model
In Commercial Distribution

  • 00816847021036 ()


  • Custom-made organ/bone anatomy model
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Full Skull Model
In Commercial Distribution

  • 00816847021029 ()


  • Custom-made organ/bone anatomy model
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Mandible Model
In Commercial Distribution

  • 00816847021012 ()


  • Custom-made organ/bone anatomy model
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Maxilla Model
In Commercial Distribution

  • 00816847021005 ()


  • Custom-made organ/bone anatomy model
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Original Anatomical Model
In Commercial Distribution

  • 00816847020992 ()


  • Custom-made organ/bone anatomy model
A template that is used as an aide to pre-contour patient’s implants.
3D SYSTEMS, INC.
Plate Bending Template
In Commercial Distribution

  • 00816847020985 ()


  • Surgical implant template, single-use
A template that is used as an aide to pre-contour patient’s implants.
3D SYSTEMS, INC.
Plate Bending Template with Predictive Hole Placement
In Commercial Distribution

  • 00816847020978 ()


  • Surgical implant template, single-use
A physical template that can be positioned at the osteotomy site that allows the physician the ability to precisely drill the bone screw holes that position the implant positioning or osteotomy guides.
3D SYSTEMS, INC.
Bone Osteotomy Guide
In Commercial Distribution

  • 00816847020961 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template that can be positioned at the osteotomy site that allows the physician the ability to precisely drill the bone screw holes that position the implant positioning or osteotomy guides.
3D SYSTEMS, INC.
Bone Osteotomy Marking Guide
In Commercial Distribution

  • 00816847020954 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Bone Osteotomy Template
In Commercial Distribution

  • 00816847020947 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Resection Guide
In Commercial Distribution

  • 00816847020930 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Maxillofacial Marking Guide
In Commercial Distribution

  • 00816847020923 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Maxillofacial Cutting Guide
In Commercial Distribution

  • 00816847020916 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Rib Marking Guide
In Commercial Distribution

  • 00816847020909 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Rib Cutting Guide
In Commercial Distribution

  • 00816847020893 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Scapula Marking Guide
In Commercial Distribution

  • 00816847020886 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Scapula Cutting Guide
In Commercial Distribution

  • 00816847020879 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Iliac Crest Marking Guide
In Commercial Distribution

  • 00816847020862 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Iliac Crest Cutting Guide
In Commercial Distribution

  • 00816847020855 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Maxilla Marking Guide
In Commercial Distribution

  • 00816847020848 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Maxilla Cutting Guide
In Commercial Distribution

  • 00816847020831 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Mandible Marking Guide
In Commercial Distribution

  • 00816847020824 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Mandible Cutting Guide
In Commercial Distribution

  • 00816847020817 ()


  • Custom-made orthopaedic/craniofacial surgical guide
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