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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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
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
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
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 Set Screw
SEASPINE ORTHOPEDICS CORPORATION
16-0015
In Commercial Distribution

  • 10889981003593 ()
16-0015

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 80 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7580
Not in Commercial Distribution

  • 10889981003579 ()

  • 7.5 DIA X 80 mm
15-7580

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 30 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7530
Not in Commercial Distribution

  • 10889981003470 ()

  • 7.5 DIA X 30 mm
15-7530

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 65 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7065
Not in Commercial Distribution

  • 10889981003456 ()

  • 7.0 DIA X 65 mm
15-7065

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 6.0 DIA X 40 mm
SEASPINE ORTHOPEDICS CORPORATION
15-6040
Not in Commercial Distribution

  • 10889981003258 ()

  • 6.0 DIA X 40 mm
15-6040

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 5.5 DIA X 55 mm
SEASPINE ORTHOPEDICS CORPORATION
15-5555
Not in Commercial Distribution

  • 10889981003210 ()

  • 5.5 DIA X 55 mm
15-5555

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