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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 - 10889981008567

UNI-PLANAR DLTA SCREW,5.0 X 30
SEASPINE ORTHOPEDICS CORPORATION
69-5030
In Commercial Distribution

  • 10889981008567 ()

  • 5.0 X 30
69-5030

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

Malibu - 10889981008543

UNI-PLANAR DLTA SCREW,4.5 X 60
SEASPINE ORTHOPEDICS CORPORATION
69-4560
Not in Commercial Distribution

  • 10889981008543 ()

  • 4.5 X 60
69-4560

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

Malibu - 10889981008383

Uni-Planar Reduction Screw, 7.5 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
68-7545
Not in Commercial Distribution

  • 10889981008383 ()

  • 7.5 DIA x 45mm
68-7545

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

Malibu - 10889981008369

Uni-Planar Reduction Screw, 7.5 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
68-7535
Not in Commercial Distribution

  • 10889981008369 ()

  • 7.5 DIA x 35mm
68-7535

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

Malibu - 10889981008345

Uni-Planar Reduction Screw, 7.5 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
68-7525
Not in Commercial Distribution

  • 10889981008345 ()

  • 7.5 DIA x 25mm
68-7525

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

Malibu - 10889981008321

Uni-Planar Reduction Screw, 7.0 DIA x 65mm
SEASPINE ORTHOPEDICS CORPORATION
68-7065
Not in Commercial Distribution

  • 10889981008321 ()

  • 7.0 DIA x 65mm
68-7065

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

Malibu - 10889981008314

Uni-Planar Reduction Screw, 7.0 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
68-7060
Not in Commercial Distribution

  • 10889981008314 ()

  • 7.0 DIA x 60mm
68-7060

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

Malibu - 10889981008291

Uni-Planar Reduction Screw, 7.0 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
68-7050
Not in Commercial Distribution

  • 10889981008291 ()

  • 7.0 DIA x 50mm
68-7050

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

Malibu - 10889981008260

Uni-Planar Reduction Screw, 7.0 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
68-7035
Not in Commercial Distribution

  • 10889981008260 ()

  • 7.0 DIA x 35mm
68-7035

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

Malibu - 10889981008253

Uni-Planar Reduction Screw, 7.0 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
68-7030
Not in Commercial Distribution

  • 10889981008253 ()

  • 7.0 DIA x 30mm
68-7030

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