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 Type Device Class Implantable

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Newport 4.75 X 50mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4750
In Commercial Distribution

  • 10889981138813 ()

  • 4.75 X 50mm
61-4750

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 45mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4745
In Commercial Distribution

  • 10889981138806 ()

  • 4.75 X 45mm
61-4745

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 40mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4740
In Commercial Distribution

  • 10889981138790 ()

  • 4.75 X 40mm
61-4740

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 35mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4735
In Commercial Distribution

  • 10889981138783 ()

  • 4.75 X 35mm
61-4735

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 30mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4730
In Commercial Distribution

  • 10889981138776 ()

  • 4.75 X 30mm
61-4730

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 95mm
Seaspine, Inc.
63-7595
Not in Commercial Distribution

  • M5566375951 ()
  • 10381780004974 ()

  • Ø7.5 x 95mm
63-7595

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 90mm
Seaspine, Inc.
63-7590
Not in Commercial Distribution

  • M5566375901 ()
  • 10381780004967 ()

  • ؘ7.5 x 90mm
63-7590

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 85mm
Seaspine, Inc.
63-7585
Not in Commercial Distribution

  • M5566375851 ()
  • 10381780004950 ()

  • Ø7.5 x 85mm
63-7585

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 80mm
Seaspine, Inc.
63-7580
Not in Commercial Distribution

  • M5566375801 ()
  • 10381780004943 ()

  • Ø7.5 x 80mm
63-7580

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 75mm
Seaspine, Inc.
63-7575
Not in Commercial Distribution

  • M5566375751 ()
  • 10381780004936 ()

  • Ø7.5 x 75mm
63-7575

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 70mm
Seaspine, Inc.
63-7570
Not in Commercial Distribution

  • M5566375701 ()
  • 10381780004929 ()

  • Ø7.5 x 70mm
63-7570

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 65mm
Seaspine, Inc.
63-7565
Not in Commercial Distribution

  • M5566375651 ()
  • 10381780004912 ()

  • Ø7.5 x 65mm
63-7565

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 60mm
Seaspine, Inc.
63-7560
Not in Commercial Distribution

  • M5566375601 ()
  • 10381780004905 ()

  • Ø7.5 x 60mm
63-7560

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 55mm
Seaspine, Inc.
63-7555
Not in Commercial Distribution

  • M5566375551 ()
  • 10381780004899 ()

  • Ø7.5 x 55mm
63-7555

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 50mm
Seaspine, Inc.
63-7550
Not in Commercial Distribution

  • M5566375501 ()
  • 10381780004882 ()

  • Ø7.5 x 50mm
63-7550

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 45mm
Seaspine, Inc.
63-7545
Not in Commercial Distribution

  • M5566375451 ()
  • 10381780004875 ()

  • Ø7.5 x 45mm
63-7545

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 40mm
Seaspine, Inc.
63-7540
Not in Commercial Distribution

  • M5566375401 ()
  • 10381780004868 ()

  • Ø7.5 x 40mm
63-7540

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 35mm
Seaspine, Inc.
63-7535
Not in Commercial Distribution

  • M5566375351 ()
  • 10381780004851 ()

  • Ø7.5 x 35mm
63-7535

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 30mm
Seaspine, Inc.
63-7530
Not in Commercial Distribution

  • M5566375301 ()
  • 10381780004844 ()

  • Ø7.5 x 30mm
63-7530

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 25mm
Seaspine, Inc.
63-7525
Not in Commercial Distribution

  • M5566375251 ()
  • 10381780004837 ()

  • Ø7.5 x 25mm
63-7525

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 110mm
Seaspine, Inc.
63-7510
Not in Commercial Distribution

  • M5566375101 ()
  • 10381780004820 ()

  • Ø7.5 x 110mm
63-7510

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 105mm
Seaspine, Inc.
63-7505
Not in Commercial Distribution

  • M5566375051 ()
  • 10381780004813 ()

  • Ø7.5 x 105mm
63-7505

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.5 x 100mm
Seaspine, Inc.
63-7500
Not in Commercial Distribution

  • M5566375001 ()
  • 10381780004806 ()

  • Ø7.5 x 100mm
63-7500

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.0 x 70mm
Seaspine, Inc.
63-7070
Not in Commercial Distribution

  • M5566370701 ()
  • 10381780004790 ()

  • Ø7.0 x 70mm
63-7070

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.0 x 65mm
Seaspine, Inc.
63-7065
Not in Commercial Distribution

  • M5566370651 ()
  • 10381780004783 ()

  • Ø7.0 x 65mm
63-7065

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.0 x 60mm
Seaspine, Inc.
63-7060
Not in Commercial Distribution

  • M5566370601 ()
  • 10381780004776 ()

  • Ø7.0 x 60mm
63-7060

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.0 x 55mm
Seaspine, Inc.
63-7055
Not in Commercial Distribution

  • M5566370551 ()
  • 10381780004769 ()

  • Ø7.0 x 55mm
63-7055

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.0 x 50mm
Seaspine, Inc.
63-7050
Not in Commercial Distribution

  • M5566370501 ()
  • 10381780004752 ()

  • Ø7.0 x 50mm
63-7050

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.0 x 45mm
Seaspine, Inc.
63-7045
Not in Commercial Distribution

  • M5566370451 ()
  • 10381780004745 ()

  • Ø7.0 x 45mm
63-7045

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.0 x 40mm
Seaspine, Inc.
63-7040
Not in Commercial Distribution

  • M5566370401 ()
  • 10381780004738 ()

  • Ø7.0 x 40mm
63-7040

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.0 x 35mm
Seaspine, Inc.
63-7035
Not in Commercial Distribution

  • M5566370351 ()
  • 10381780004721 ()

  • Ø7.0 x 35mm
63-7035

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.0 x 30mm
Seaspine, Inc.
63-7030
Not in Commercial Distribution

  • M5566370301 ()
  • 10381780004714 ()

  • Ø7.0 x 30mm
63-7030

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø7.0 x 25mm
Seaspine, Inc.
63-7025
Not in Commercial Distribution

  • M5566370251 ()
  • 10381780004707 ()

  • Ø7.0 x 25mm
63-7025

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 95mm
Seaspine, Inc.
63-6595
Not in Commercial Distribution

  • M5566365951 ()
  • 10381780004691 ()

  • Ø6.5 x 95mm
63-6595

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 90mm
Seaspine, Inc.
63-6590
Not in Commercial Distribution

  • M5566365901 ()
  • 10381780004684 ()

  • Ø6.5 x 90mm
63-6590

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 85mm
Seaspine, Inc.
63-6585
Not in Commercial Distribution

  • M5566365851 ()
  • 10381780004677 ()

  • Ø6.5 x 85mm
63-6585

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 80mm
Seaspine, Inc.
63-6580
Not in Commercial Distribution

  • M5566365801 ()
  • 10381780004660 ()

  • Ø6.5 x 80mm
63-6580

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 75mm
Seaspine, Inc.
63-6575
Not in Commercial Distribution

  • M5566365751 ()
  • 10381780004653 ()

  • Ø6.5 x 75mm
63-6575

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 70mm
Seaspine, Inc.
63-6570
Not in Commercial Distribution

  • M5566365701 ()
  • 10381780004646 ()

  • Ø6.5 x 70mm
63-6570

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Dlta Polyaxial Screw, Ø6.5 x 65mm
Seaspine, Inc.
63-6565
Not in Commercial Distribution

  • M5566365651 ()
  • 10381780004639 ()

  • Ø6.5 x 65mm
63-6565

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