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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 Type Device Class Implantable

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SeaSpine NewPort Spinal System - 10889981138813

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

SeaSpine NewPort Spinal System - 10889981138806

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

SeaSpine NewPort Spinal System - 10889981138790

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

SeaSpine NewPort Spinal System - 10889981138783

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

SeaSpine NewPort Spinal System - 10889981138776

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

Malibu - 10889981003753

Monoaxial Screw, 6.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
16-6545
In Commercial Distribution

  • 10889981003753 ()

  • 6.5 x 45mm
16-6545

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

Malibu - 10889981003739

Monoaxial Screw, 6.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
16-6535
In Commercial Distribution

  • 10889981003739 ()

  • 6.5 x 35mm
16-6535

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

Malibu - 10889981003715

MONOAXIAL SCREW, 5.5 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
16-5555
Not in Commercial Distribution

  • 10889981003715 ()

  • 5.5 x 55mm
16-5555

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

Malibu - 10889981003609

MONOAXIAL SCREW, 4.5 x 20mm
SEASPINE ORTHOPEDICS CORPORATION
16-4520
Not in Commercial Distribution

  • 10889981003609 ()

  • 4.5 x 20mm
16-4520

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

Malibu - 10889981003593

Malibu Set Screw
SEASPINE ORTHOPEDICS CORPORATION
16-0015
In Commercial Distribution

  • 10889981003593 ()
16-0015

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