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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Uni-Planar Reduction Screw, 5.0 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
68-5040
Not in Commercial Distribution

  • 10889981007850 ()

  • 5.0 DIA x 40mm
68-5040

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 5.0 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
68-5030
Not in Commercial Distribution

  • 10889981007836 ()

  • 5.0 DIA x 30mm
68-5030

  • Bone-screw internal spinal fixation system, non-sterile
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
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
Uni-Planar Reduction Screw, 4.5 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
68-4545
Not in Commercial Distribution

  • 10889981007782 ()

  • 4.5 DIA x 45mm
68-4545

  • Bone-screw internal spinal fixation system, non-sterile
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
Uni-Planar Screw, 7.5 DIA x 80mm
SEASPINE ORTHOPEDICS CORPORATION
67-7580
Not in Commercial Distribution

  • 10889981007720 ()

  • 7.5 DIA x 80mm
67-7580

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 7.5 DIA x 65mm
SEASPINE ORTHOPEDICS CORPORATION
67-7565
Not in Commercial Distribution

  • 10889981007690 ()

  • 7.5 DIA x 65mm
67-7565

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 7.5 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
67-7550
Not in Commercial Distribution

  • 10889981007669 ()

  • 7.5 DIA x 50mm
67-7550

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 7.5 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
67-7540
Not in Commercial Distribution

  • 10889981007645 ()

  • 7.5 DIA x 40mm
67-7540

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 7.5 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
67-7535
Not in Commercial Distribution

  • 10889981007638 ()

  • 7.5 DIA x 35mm
67-7535

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 7.5 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
67-7525
Not in Commercial Distribution

  • 10889981007614 ()

  • 7.5 DIA x 25mm
67-7525

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 7.0 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
67-7060
Not in Commercial Distribution

  • 10889981007584 ()

  • 7.0 DIA x 60mm
67-7060

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 7.0 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
67-7050
Not in Commercial Distribution

  • 10889981007560 ()

  • 7.0 DIA x 50mm
67-7050

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 7.0 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
67-7035
Not in Commercial Distribution

  • 10889981007539 ()

  • 7.0 DIA x 35mm
67-7035

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 6.5 DIA x 95mm
SEASPINE ORTHOPEDICS CORPORATION
67-6595
Not in Commercial Distribution

  • 10889981007508 ()

  • 6.5 DIA x 95mm
67-6595

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 6.5 DIA x 85mm
SEASPINE ORTHOPEDICS CORPORATION
67-6585
Not in Commercial Distribution

  • 10889981007485 ()

  • 6.5 DIA x 85mm
67-6585

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 6.5 DIA x 80mm
SEASPINE ORTHOPEDICS CORPORATION
67-6580
Not in Commercial Distribution

  • 10889981007478 ()

  • 6.5 DIA x 80mm
67-6580

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 6.5 DIA x 70mm
SEASPINE ORTHOPEDICS CORPORATION
67-6570
Not in Commercial Distribution

  • 10889981007454 ()

  • 6.5 DIA x 70mm
67-6570

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 6.5 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
67-6560
Not in Commercial Distribution

  • 10889981007430 ()

  • 6.5 DIA x 60mm
67-6560

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