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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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Malibu - 10889981007812

Uni-Planar Reduction Screw, 4.5 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
68-4560
Not in Commercial Distribution

  • 10889981007812 ()

  • 4.5 DIA x 60mm
68-4560

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

Malibu - 10889981007805

Uni-Planar Reduction Screw, 4.5 DIA x 55mm
SEASPINE ORTHOPEDICS CORPORATION
68-4555
Not in Commercial Distribution

  • 10889981007805 ()

  • 4.5 DIA x 55mm
68-4555

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

Malibu - 10889981007799

Uni-Planar Reduction Screw, 4.5 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
68-4550
Not in Commercial Distribution

  • 10889981007799 ()

  • 4.5 DIA x 50mm
68-4550

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

Malibu - 10889981007775

Uni-Planar Reduction Screw, 4.5 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
68-4540
Not in Commercial Distribution

  • 10889981007775 ()

  • 4.5 DIA x 40mm
68-4540

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

Malibu - 10889981007751

Uni-Planar Reduction Screw, 4.5 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
68-4530
Not in Commercial Distribution

  • 10889981007751 ()

  • 4.5 DIA x 30mm
68-4530

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

Stainless Steel - 10889981114046

Malleable Rod, 400mm
SEASPINE ORTHOPEDICS CORPORATION
25-20-0400
In Commercial Distribution

  • 10889981114046 ()

  • 400mm
25-20-0400

  • Vertebral body prosthesis, non-sterile

Coral - 10889981110932

CoCr Prebent Rod 5.5 x 600mm
SEASPINE ORTHOPEDICS CORPORATION
18-21-0600
In Commercial Distribution

  • 10889981110932 ()

  • 5.5 X 600mm
18-21-0600

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

Coral - 10889981110260

CoCr Prebent Rod 5.5 x 25
SEASPINE ORTHOPEDICS CORPORATION
18-19-0025
In Commercial Distribution

  • 10889981110260 ()

  • 5.5 x 25
18-19-0025

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

Coral - 10889981110253

CoCr Prebent Rod 5.5 x 20
SEASPINE ORTHOPEDICS CORPORATION
18-19-0020
In Commercial Distribution

  • 10889981110253 ()

  • 5.5 x 20
18-19-0020

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

Coral - 10889981110239

CoCr Str. Rod 5.5 x 400
SEASPINE ORTHOPEDICS CORPORATION
18-18-0400
In Commercial Distribution

  • 10889981110239 ()

  • 5.5 x 400
18-18-0400

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