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, 5.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
16-5550
In Commercial Distribution

  • 10889981003708 ()

  • 5.5 x 50mm
16-5550

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 5.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
16-5545
In Commercial Distribution

  • 10889981003692 ()

  • 5.5 x 45mm
16-5545

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 5.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
16-5540
In Commercial Distribution

  • 10889981003685 ()

  • 5.5 x 40mm
16-5540

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 5.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
16-5535
In Commercial Distribution

  • 10889981003678 ()

  • 5.5 x 35mm
16-5535

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 5.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
16-5530
In Commercial Distribution

  • 10889981003661 ()

  • 5.5 x 30mm
16-5530

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 5.5 x 25mm
SEASPINE ORTHOPEDICS CORPORATION
16-5525
In Commercial Distribution

  • 10889981003654 ()

  • 5.5 x 25mm
16-5525

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 4.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
16-4540
In Commercial Distribution

  • 10889981003647 ()

  • 4.5 x 40mm
16-4540

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 4.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
16-4535
In Commercial Distribution

  • 10889981003630 ()

  • 4.5 x 35mm
16-4535

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 4.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
16-4530
In Commercial Distribution

  • 10889981003623 ()

  • 4.5 x 30mm
16-4530

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL SCREW, 4.5 x 25mm
SEASPINE ORTHOPEDICS CORPORATION
16-4525
In Commercial Distribution

  • 10889981003616 ()

  • 4.5 x 25mm
16-4525

  • 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
MONOAXIAL LOCKING CAP
SEASPINE ORTHOPEDICS CORPORATION
16-0010
In Commercial Distribution

  • 10889981003586 ()
16-0010

  • 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 75 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7575
Not in Commercial Distribution

  • 10889981003562 ()

  • 7.5 DIA X 75 mm
15-7575

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 70 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7570
Not in Commercial Distribution

  • 10889981003555 ()

  • 7.5 DIA X 70 mm
15-7570

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 65 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7565
Not in Commercial Distribution

  • 10889981003548 ()

  • 7.5 DIA X 65 mm
15-7565

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 60 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7560
Not in Commercial Distribution

  • 10889981003531 ()

  • 7.5 DIA X 60 mm
15-7560

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 55 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7555
In Commercial Distribution

  • 10889981003524 ()

  • 7.5 DIA X 55 mm
15-7555

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 50 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7550
In Commercial Distribution

  • 10889981003517 ()

  • 7.5 DIA X 50 mm
15-7550

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 45 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7545
In Commercial Distribution

  • 10889981003500 ()

  • 7.5 DIA X 45 mm
15-7545

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 40 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7540
In Commercial Distribution

  • 10889981003494 ()

  • 7.5 DIA X 40 mm
15-7540

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.5 DIA X 35 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7535
In Commercial Distribution

  • 10889981003487 ()

  • 7.5 DIA X 35 mm
15-7535

  • 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 70 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7070
Not in Commercial Distribution

  • 10889981003463 ()

  • 7.0 DIA X 70 mm
15-7070

  • 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 7.0 DIA X 60 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7060
Not in Commercial Distribution

  • 10889981003449 ()

  • 7.0 DIA X 60 mm
15-7060

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 55 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7055
Not in Commercial Distribution

  • 10889981003432 ()

  • 7.0 DIA X 55 mm
15-7055

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 50 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7050
Not in Commercial Distribution

  • 10889981003425 ()

  • 7.0 DIA X 50 mm
15-7050

  • Bone-screw internal spinal fixation system, non-sterile
MALIBU DLTA SCREW 7.0 DIA X 45 mm
SEASPINE ORTHOPEDICS CORPORATION
15-7045
Not in Commercial Distribution

  • 10889981003418 ()

  • 7.0 DIA X 45 mm
15-7045

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