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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™ - 10889981030834

PRECONTOURED ESS PLUS ROD, 5.5 x 600 mm
SEASPINE ORTHOPEDICS CORPORATION
15-3600
Not in Commercial Distribution

  • 10889981030834 ()

  • 5.5mm x 600 mm
15-3600

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

Malibu™ - 10889981030827

PRECONTOURED ESS PLUS ROD, 5.5 x 500 mm
SEASPINE ORTHOPEDICS CORPORATION
15-3500
In Commercial Distribution

  • 10889981030827 ()

  • 5.5mm x 500 mm
15-3500

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

Malibu™ - 10889981030810

PRECONTOURED ESS PLUS ROD, 5.5 x 400 mm
SEASPINE ORTHOPEDICS CORPORATION
15-3400
In Commercial Distribution

  • 10889981030810 ()

  • 5.5mm x 400 mm
15-3400

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

Malibu™ - 10889981030803

PRECONTOURED ESS PLUS ROD, 5.5 x 300 mm
SEASPINE ORTHOPEDICS CORPORATION
15-3300
In Commercial Distribution

  • 10889981030803 ()

  • 5.5mm x 300 mm
15-3300

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

Malibu™ - 10889981030797

ESS PLUS ROD, 5.5 x 450 mm
SEASPINE ORTHOPEDICS CORPORATION
15-2450
In Commercial Distribution

  • 10889981030797 ()

  • 5.5mm x 450 mm
15-2450

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