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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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4mm Hex Driver Long
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0076
In Commercial Distribution

  • B432360CAS00760 ()


  • Robotic surgical navigation system application software
CAS Flex Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0068
In Commercial Distribution

  • B432360CAS00680 ()


  • Robotic surgical navigation system application software
Coupler Wrench
ARTHREX, INC.
AR-8964-28
In Commercial Distribution

  • 00888867514522 ()
AR-8964-28

  • External orthopaedic fixation system, reusable
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.
Fibula Cutting Guide
In Commercial Distribution

  • 00816847020794 ()


  • 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.
Fibula Marking Guide with Implant Placement
In Commercial Distribution

  • 00816847020787 ()


  • 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.
Fibula Cutting Guide with Implant Placement
In Commercial Distribution

  • 00816847020770 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Surgical Positioning Guide
In Commercial Distribution

  • 00816847020763 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Surgical Positioning Template
In Commercial Distribution

  • 00816847020756 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical guide used to hold bone in a position dictated by the surgeon for a limited amount of time. Once the bone repositioning guide stabilizes the position of the patient’s bone; the surgeon can determine a permanent solution
3D SYSTEMS, INC.
Bone Repositioning Guide
In Commercial Distribution

  • 00816847020749 ()


  • Custom-made orthopaedic/craniofacial surgical guide
A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Maxillofacial Positioning Guide
In Commercial Distribution

  • 00816847020732 ()


  • Custom-made orthopaedic/craniofacial surgical guide
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