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 Device Size Type Device Class Implantable

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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
Uni-Planar Reduction Screw, 7.0 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
68-7025
Not in Commercial Distribution

  • 10889981008246 ()

  • 7.0 DIA x 25mm
68-7025

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 95mm
SEASPINE ORTHOPEDICS CORPORATION
68-6595
Not in Commercial Distribution

  • 10889981008239 ()

  • 6.5 DIA x 95mm
68-6595

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 90mm
SEASPINE ORTHOPEDICS CORPORATION
68-6590
Not in Commercial Distribution

  • 10889981008222 ()

  • 6.5 DIA x 90mm
68-6590

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 85mm
SEASPINE ORTHOPEDICS CORPORATION
68-6585
Not in Commercial Distribution

  • 10889981008215 ()

  • 6.5 DIA x 85mm
68-6585

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 80mm
SEASPINE ORTHOPEDICS CORPORATION
68-6580
Not in Commercial Distribution

  • 10889981008208 ()

  • 6.5 DIA x 80mm
68-6580

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 75mm
SEASPINE ORTHOPEDICS CORPORATION
68-6575
Not in Commercial Distribution

  • 10889981008192 ()

  • 6.5 DIA x 75mm
68-6575

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 70mm
SEASPINE ORTHOPEDICS CORPORATION
68-6570
Not in Commercial Distribution

  • 10889981008185 ()

  • 6.5 DIA x 70mm
68-6570

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 65mm
SEASPINE ORTHOPEDICS CORPORATION
68-6565
Not in Commercial Distribution

  • 10889981008178 ()

  • 6.5 DIA x 65mm
68-6565

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
68-6560
Not in Commercial Distribution

  • 10889981008161 ()

  • 6.5 DIA x 60mm
68-6560

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 55mm
SEASPINE ORTHOPEDICS CORPORATION
68-6555
In Commercial Distribution

  • 10889981008154 ()

  • 6.5 DIA x 55mm
68-6555

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
68-6550
Not in Commercial Distribution

  • 10889981008147 ()

  • 6.5 DIA x 50mm
68-6550

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
68-6545
Not in Commercial Distribution

  • 10889981008130 ()

  • 6.5 DIA x 45mm
68-6545

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
68-6540
Not in Commercial Distribution

  • 10889981008123 ()

  • 6.5 DIA x 40mm
68-6540

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
68-6535
Not in Commercial Distribution

  • 10889981008116 ()

  • 6.5 DIA x 35mm
68-6535

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
68-6530
Not in Commercial Distribution

  • 10889981008109 ()

  • 6.5 DIA x 30mm
68-6530

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
68-6525
Not in Commercial Distribution

  • 10889981008093 ()

  • 6.5 DIA x 25mm
68-6525

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 110mm
SEASPINE ORTHOPEDICS CORPORATION
68-6510
Not in Commercial Distribution

  • 10889981008086 ()

  • 6.5 DIA x 110mm
68-6510

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 105mm
SEASPINE ORTHOPEDICS CORPORATION
68-6505
Not in Commercial Distribution

  • 10889981008079 ()

  • 6.5 DIA x 105mm
68-6505

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.5 DIA x 100mm
SEASPINE ORTHOPEDICS CORPORATION
68-6500
Not in Commercial Distribution

  • 10889981008062 ()

  • 6.5 DIA x 100mm
68-6500

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.0 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
68-6060
Not in Commercial Distribution

  • 10889981008055 ()

  • 6.0 DIA x 60mm
68-6060

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.0 DIA x 55mm
SEASPINE ORTHOPEDICS CORPORATION
68-6055
Not in Commercial Distribution

  • 10889981008048 ()

  • 6.0 DIA x 55mm
68-6055

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.0 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
68-6050
Not in Commercial Distribution

  • 10889981008031 ()

  • 6.0 DIA x 50mm
68-6050

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.0 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
68-6045
Not in Commercial Distribution

  • 10889981008024 ()

  • 6.0 DIA x 45mm
68-6045

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.0 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
68-6040
Not in Commercial Distribution

  • 10889981008017 ()

  • 6.0 DIA x 40mm
68-6040

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.0 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
68-6035
Not in Commercial Distribution

  • 10889981008000 ()

  • 6.0 DIA x 35mm
68-6035

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.0 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
68-6030
Not in Commercial Distribution

  • 10889981007997 ()

  • 6.0 DIA x 30mm
68-6030

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 6.0 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
68-6025
Not in Commercial Distribution

  • 10889981007980 ()

  • 6.0 DIA x 25mm
68-6025

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 5.5 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
68-5560
Not in Commercial Distribution

  • 10889981007973 ()

  • 5.5 DIA x 60mm
68-5560

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 5.5 DIA x 55mm
SEASPINE ORTHOPEDICS CORPORATION
68-5555
Not in Commercial Distribution

  • 10889981007966 ()

  • 5.5 DIA x 55mm
68-5555

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 5.5 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
68-5550
Not in Commercial Distribution

  • 10889981007959 ()

  • 5.5 DIA x 50mm
68-5550

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 5.5 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
68-5545
Not in Commercial Distribution

  • 10889981007942 ()

  • 5.5 DIA x 45mm
68-5545

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 5.5 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
68-5540
Not in Commercial Distribution

  • 10889981007935 ()

  • 5.5 DIA x 40mm
68-5540

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 5.5 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
68-5535
Not in Commercial Distribution

  • 10889981007928 ()

  • 5.5 DIA x 35mm
68-5535

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 5.5 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
68-5530
Not in Commercial Distribution

  • 10889981007911 ()

  • 5.5 DIA x 30mm
68-5530

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 5.5 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
68-5525
Not in Commercial Distribution

  • 10889981007904 ()

  • 5.5 DIA x 25mm
68-5525

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 5.0 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
68-5050
Not in Commercial Distribution

  • 10889981007874 ()

  • 5.0 DIA x 50mm
68-5050

  • Bone-screw internal spinal fixation system, non-sterile
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, 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 35mm
SEASPINE ORTHOPEDICS CORPORATION
68-4535
Not in Commercial Distribution

  • 10889981007768 ()

  • 4.5 DIA x 35mm
68-4535

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 4.5 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
68-4525
Not in Commercial Distribution

  • 10889981007744 ()

  • 4.5 DIA x 25mm
68-4525

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Reduction Screw, 4.5 DIA x 20mm
SEASPINE ORTHOPEDICS CORPORATION
68-4520
Not in Commercial Distribution

  • 10889981007737 ()

  • 4.5 DIA x 20mm
68-4520

  • 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 75mm
SEASPINE ORTHOPEDICS CORPORATION
67-7575
Not in Commercial Distribution

  • 10889981007713 ()

  • 7.5 DIA x 75mm
67-7575

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 7.5 DIA x 70mm
SEASPINE ORTHOPEDICS CORPORATION
67-7570
Not in Commercial Distribution

  • 10889981007706 ()

  • 7.5 DIA x 70mm
67-7570

  • 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 60mm
SEASPINE ORTHOPEDICS CORPORATION
67-7560
Not in Commercial Distribution

  • 10889981007683 ()

  • 7.5 DIA x 60mm
67-7560

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 7.5 DIA x 55mm
SEASPINE ORTHOPEDICS CORPORATION
67-7555
Not in Commercial Distribution

  • 10889981007676 ()

  • 7.5 DIA x 55mm
67-7555

  • 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 45mm
SEASPINE ORTHOPEDICS CORPORATION
67-7545
Not in Commercial Distribution

  • 10889981007652 ()

  • 7.5 DIA x 45mm
67-7545

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