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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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Newport - 10889981005146

NewPort Double Lead Screw, DIA 5.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
61-5545
In Commercial Distribution

  • 10889981005146 ()

  • DIA 5.5 x 45mm
61-5545

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

Newport - 10889981005139

NewPort Double Lead Screw, DIA 5.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
61-5540
In Commercial Distribution

  • 10889981005139 ()

  • DIA 5.5 x 40mm
61-5540

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

Newport - 10889981005122

NewPort Double Lead Screw, DIA 5.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
61-5535
In Commercial Distribution

  • 10889981005122 ()

  • DIA 5.5 x 35mm
61-5535

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

Newport - 10889981005115

NewPort Double Lead Screw, DIA 5.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
61-5530
In Commercial Distribution

  • 10889981005115 ()

  • DIA 5.5 x 30mm
61-5530

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

Newport - 10889981005009

NewPort MIS Screw, DIA 7.0 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
60-7045
Not in Commercial Distribution

  • 10889981005009 ()

  • DIA 7.0 x 45mm
60-7045

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

Newport - 10889981004996

NewPort MIS Screw, DIA 7.0 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
60-7040
Not in Commercial Distribution

  • 10889981004996 ()

  • DIA 7.0 x 40mm
60-7040

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

Malibu - 10889981004729

Cannulated Polyaxial Screw, 8.5 x 70MM
SEASPINE ORTHOPEDICS CORPORATION
18-8570
Not in Commercial Distribution

  • 10889981004729 ()

  • 8.5 x 70MM
18-8570

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

Malibu - 10889981004644

Cannulated Polyaxial Screw, 8.5 x 30MM
SEASPINE ORTHOPEDICS CORPORATION
18-8530
Not in Commercial Distribution

  • 10889981004644 ()

  • 8.5 x 30MM
18-8530

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

Malibu - 10889981004637

Cannulated Polyaxial Screw, 8.0 x 80MM
SEASPINE ORTHOPEDICS CORPORATION
18-8080
Not in Commercial Distribution

  • 10889981004637 ()

  • 8.0 x 80MM
18-8080

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

Malibu - 10889981004620

Cannulated Polyaxial Screw, 8.0 x 75MM
SEASPINE ORTHOPEDICS CORPORATION
18-8075
Not in Commercial Distribution

  • 10889981004620 ()

  • 8.0 x 75MM
18-8075

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