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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Malibu Polyaxial Screw, 4.5 x 60mm
Seaspine, Inc.
12-4560
Not in Commercial Distribution

  • M5561245601 ()
  • 10381780000969 ()

  • 4.5 x 60mm
12-4560

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 4.5 x 55mm
Seaspine, Inc.
12-4555
Not in Commercial Distribution

  • M5561245551 ()
  • 10381780000952 ()

  • 4.5 x 55mm
12-4555

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 8.0 x 60mm
Seaspine, Inc.
11-8060
Not in Commercial Distribution

  • M5561180601 ()
  • 10381780000945 ()

  • 8.0 x 60mm
11-8060

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 8.0 x 55mm
Seaspine, Inc.
11-8055
Not in Commercial Distribution

  • M5561180551 ()
  • 10381780000938 ()

  • 8.0 x 55mm
11-8055

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 8.0 x 35mm
Seaspine, Inc.
11-8035
Not in Commercial Distribution

  • M5561180351 ()
  • 10381780000921 ()

  • 8.0 x 35mm
11-8035

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 8.0 x 30mm
Seaspine, Inc.
11-8030
Not in Commercial Distribution

  • M5561180301 ()
  • 10381780000914 ()

  • 8.0 x 30mm
11-8030

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.75 x 60 mm
Seaspine, Inc.
11-6760
Not in Commercial Distribution

  • M5561167601 ()
  • 10381780000907 ()

  • 6.75 x 60 mm
11-6760

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.75 x 30 mm
Seaspine, Inc.
11-6730
Not in Commercial Distribution

  • M5561167301 ()
  • 10381780000891 ()

  • 6.75 x 30 mm
11-6730

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.0 x 60 mm
Seaspine, Inc.
11-6060
Not in Commercial Distribution

  • M5561160601 ()
  • 10381780000884 ()

  • 6.0 x 60 mm
11-6060

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.0 x 55 mm
Seaspine, Inc.
11-6055
Not in Commercial Distribution

  • M5561160551 ()
  • 10381780000877 ()

  • 6.0 x 55 mm
11-6055

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.0 x 50 mm
Seaspine, Inc.
11-6050
Not in Commercial Distribution

  • M5561160501 ()
  • 10381780000860 ()

  • 6.0 x 50 mm
11-6050

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.0 x 45 mm
Seaspine, Inc.
11-6045
Not in Commercial Distribution

  • M5561160451 ()
  • 10381780000853 ()

  • 6.0 x 45 mm
11-6045

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.0 x 40 mm
Seaspine, Inc.
11-6040
Not in Commercial Distribution

  • M5561160401 ()
  • 10381780000846 ()

  • 6.0 x 40 mm
11-6040

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.0 x 35 mm
Seaspine, Inc.
11-6035
Not in Commercial Distribution

  • M5561160351 ()
  • 10381780000839 ()

  • 6.0 x 35 mm
11-6035

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.0 x 30 mm
Seaspine, Inc.
11-6030
Not in Commercial Distribution

  • M5561160301 ()
  • 10381780000822 ()

  • 6.0 x 30 mm
11-6030

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 6.0 x 25 mm
Seaspine, Inc.
11-6025
Not in Commercial Distribution

  • M5561160251 ()
  • 10381780000815 ()

  • 6.0 x 25 mm
11-6025

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 5.5 x 55 mm
Seaspine, Inc.
11-5555
Not in Commercial Distribution

  • M5561155551 ()
  • 10381780000808 ()

  • 5.5 x 55 mm
11-5555

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 4.75 x 55 mm
Seaspine, Inc.
11-4755
Not in Commercial Distribution

  • M5561147551 ()
  • 10381780000792 ()

  • 4.75 x 55 mm
11-4755

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 4.75 x 50 mm
Seaspine, Inc.
11-4750
Not in Commercial Distribution

  • M5561147501 ()
  • 10381780000785 ()

  • 4.75 x 50 mm
11-4750

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 4.75 x 45 mm
Seaspine, Inc.
11-4745
Not in Commercial Distribution

  • M5561147451 ()
  • 10381780000778 ()

  • 4.75 x 45 mm
11-4745

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 4.75 x 40 mm
Seaspine, Inc.
11-4740
Not in Commercial Distribution

  • M5561147401 ()
  • 10381780000761 ()

  • 4.75 x 40 mm
11-4740

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 4.75 x 35 mm
Seaspine, Inc.
11-4735
Not in Commercial Distribution

  • M5561147351 ()
  • 10381780000754 ()

  • 4.75 x 35 mm
11-4735

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 4.75 x 30 mm
Seaspine, Inc.
11-4730
Not in Commercial Distribution

  • M5561147301 ()
  • 10381780000747 ()

  • 4.75 x 30 mm
11-4730

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw 4.75 x 25 mm
Seaspine, Inc.
11-4725
Not in Commercial Distribution

  • M5561147251 ()
  • 10381780000730 ()

  • 4.75 x 25 mm
11-4725

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 8.0 x 30 mm
Seaspine, Inc.
10-8030
Not in Commercial Distribution

  • M5561080301 ()
  • 10381780000723 ()

  • 8.0 x 30 mm
10-8030

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 6.0 x 30 mm
Seaspine, Inc.
10-6030
Not in Commercial Distribution

  • M5561060301 ()
  • 10381780000716 ()

  • 6.0 x 30 mm
10-6030

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 6.0 x 25 mm
Seaspine, Inc.
10-6025
Not in Commercial Distribution

  • M5561060251 ()
  • 10381780000709 ()

  • 6.0 x 25 mm
10-6025

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.75 x 55 mm
Seaspine, Inc.
10-4755
Not in Commercial Distribution

  • M5561047551 ()
  • 10381780000693 ()

  • 4.75 x 55 mm
10-4755

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.75 x 50 mm
Seaspine, Inc.
10-4750
Not in Commercial Distribution

  • M5561047501 ()
  • 10381780000686 ()

  • 4.75 x 50 mm
10-4750

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.75 x 45 mm
Seaspine, Inc.
10-4745
Not in Commercial Distribution

  • M5561047451 ()
  • 10381780000679 ()

  • 4.75 x 45 mm
10-4745

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.75 x 40 mm
Seaspine, Inc.
10-4740
Not in Commercial Distribution

  • M5561047401 ()
  • 10381780000662 ()

  • 4.75 x 40 mm
10-4740

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 35mm
Seaspine, Inc.
61-7535
Not in Commercial Distribution

  • M5566175351 ()
  • 10381780031352 ()

  • DIA 7.5 x 35mm
61-7535

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 105mm
Seaspine, Inc.
61-7505
Not in Commercial Distribution

  • M5566175051 ()
  • 10381780031321 ()

  • DIA 7.5 x 105mm
61-7505

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 100mm
Seaspine, Inc.
61-7500
Not in Commercial Distribution

  • M5566175001 ()
  • 10381780031314 ()

  • DIA 7.5 x 100mm
61-7500

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 85mm
Seaspine, Inc.
61-7085
Not in Commercial Distribution

  • M5566170851 ()
  • 10381780031284 ()

  • DIA 7.0 x 85mm
61-7085

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 80mm
Seaspine, Inc.
61-7080
Not in Commercial Distribution

  • M5566170801 ()
  • 10381780031277 ()

  • DIA 7.0 x 80mm
61-7080

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 70mm
Seaspine, Inc.
61-7070
Not in Commercial Distribution

  • M5566170701 ()
  • 10381780031253 ()

  • DIA 7.0 x 70mm
61-7070

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 65mm
Seaspine, Inc.
61-7065
Not in Commercial Distribution

  • M5566170651 ()
  • 10381780031246 ()

  • DIA 7.0 x 65mm
61-7065

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 60mm
Seaspine, Inc.
61-7060
Not in Commercial Distribution

  • M5566170601 ()
  • 10381780031239 ()

  • DIA 7.0 x 60mm
61-7060

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 55mm
Seaspine, Inc.
61-7055
Not in Commercial Distribution

  • M5566170551 ()
  • 10381780031222 ()

  • DIA 7.0 x 55mm
61-7055

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 50mm
Seaspine, Inc.
61-7050
Not in Commercial Distribution

  • M5566170501 ()
  • 10381780031215 ()

  • DIA 7.0 x 50mm
61-7050

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 45mm
Seaspine, Inc.
61-7045
Not in Commercial Distribution

  • M5566170451 ()
  • 10381780031208 ()

  • DIA 7.0 x 45mm
61-7045

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 40mm
Seaspine, Inc.
61-7040
Not in Commercial Distribution

  • M5566170401 ()
  • 10381780031192 ()

  • DIA 7.0 x 40mm
61-7040

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 35mm
Seaspine, Inc.
61-7035
Not in Commercial Distribution

  • M5566170351 ()
  • 10381780031185 ()

  • DIA 7.0 x 35mm
61-7035

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 30mm
Seaspine, Inc.
61-7030
Not in Commercial Distribution

  • M5566170301 ()
  • 10381780031178 ()

  • DIA 7.0 x 30mm
61-7030

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 110mm
Seaspine, Inc.
61-7010
Not in Commercial Distribution

  • M5566170101 ()
  • 10381780031161 ()

  • DIA 7.0 x 110mm
61-7010

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 105mm
Seaspine, Inc.
61-7005
Not in Commercial Distribution

  • M5566170051 ()
  • 10381780031154 ()

  • DIA 7.0 x 105mm
61-7005

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.0 x 100mm
Seaspine, Inc.
61-7000
Not in Commercial Distribution

  • M5566170001 ()
  • 10381780031147 ()

  • DIA 7.0 x 100mm
61-7000

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 95mm
Seaspine, Inc.
61-6595
Not in Commercial Distribution

  • M5566165951 ()
  • 10381780031130 ()

  • DIA 6.5 x 95mm
61-6595

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 6.5 x 90mm
Seaspine, Inc.
61-6590
Not in Commercial Distribution

  • M5566165901 ()
  • 10381780031123 ()

  • DIA 6.5 x 90mm
61-6590

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