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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SpectrumTM Distraction Rod Cap
OSTEOMED LLC
217-0067
In Commercial Distribution

  • 00845694004640 ()

  • Length: 3.4 Millimeter
217-0067

  • Implantable craniofacial bone distractor
SpectrumTM Small Horizontal Bow
OSTEOMED LLC
217-0064
In Commercial Distribution

  • 00845694004619 ()

  • Angle: 36 degree
217-0064

  • Implantable craniofacial bone distractor
SpectrumTM Right Maxillary Plate Assembly
OSTEOMED LLC
217-0063
In Commercial Distribution

  • 00845694004602 ()

  • Horizontal Distraction = up to 25mm
217-0063

  • Implantable craniofacial bone distractor
SpectrumTM Left Maxillary Plate Assembly
OSTEOMED LLC
217-0062
In Commercial Distribution

  • 00845694004596 ()

  • Horizontal Distraction = up to 25mm
217-0062

  • Implantable craniofacial bone distractor
SpectrumTM Long Malar Anchor Assembly
OSTEOMED LLC
217-0061
In Commercial Distribution

  • 00845694004589 ()

  • Vertical Distraction = up to 7mm
217-0061

  • Implantable craniofacial bone distractor
SpectrumTM Short Malar Anchor Assembly
OSTEOMED LLC
217-0060
In Commercial Distribution

  • 00845694004572 ()

  • Vertical Distraction = up to 4mm
217-0060

  • Implantable craniofacial bone distractor
Logic Jr. Distractor, Straight (Left/Right)
OSTEOMED LLC
216-1002
In Commercial Distribution

  • 00845694004503 ()

  • Angle = 0deg
216-1002

  • Implantable craniofacial bone distractor
Logic Jr. Distractor, Right 52mm
OSTEOMED LLC
216-1001
In Commercial Distribution

  • 00845694004497 ()

  • Distraction Curve Radius = 52mm
216-1001

  • Implantable craniofacial bone distractor
Logic Jr. Distractor, Left 52mm
OSTEOMED LLC
216-1000
In Commercial Distribution

  • 00845694004480 ()

  • Distraction Curve Radius = 52mm
216-1000

  • Implantable craniofacial bone distractor
Activation Wire, 82mm
OSTEOMED LLC
216-0307
In Commercial Distribution

  • 00845694004466 ()

  • Length: 82 Millimeter
216-0307

  • Implantable craniofacial bone distractor
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