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,5.0 x 45mm
Seaspine, Inc.
12-5045
Not in Commercial Distribution

  • M5561250451 ()
  • 10381780001010 ()

  • 5.0 x 45mm
12-5045

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 5.0 x 40mm
Seaspine, Inc.
12-5040
Not in Commercial Distribution

  • M5561250401 ()
  • 10381780001003 ()

  • 5.0 x 40mm
12-5040

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 5.0 x 35mm
Seaspine, Inc.
12-5035
Not in Commercial Distribution

  • M5561250351 ()
  • 10381780000990 ()

  • 5.0 x 35mm
12-5035

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 5.0 x 30mm
Seaspine, Inc.
12-5030
Not in Commercial Distribution

  • M5561250301 ()
  • 10381780000983 ()

  • 5.0 x 30mm
12-5030

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Screw, 5.0 x 25mm
Seaspine, Inc.
12-5025
Not in Commercial Distribution

  • M5561250251 ()
  • 10381780000976 ()

  • 5.0 x 25mm
12-5025

  • Bone-screw internal spinal fixation system, non-sterile
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
Malibu Deformity Implant
Seaspine, Inc.
MLBDFIMP
Not in Commercial Distribution

  • M556MLBDFIMP1 ()
  • 10381780031604 ()
MLBDFIMP

  • Bone-screw internal spinal fixation system, non-sterile
Malibu 8.0 Implant
Seaspine, Inc.
MLB8IMP
Not in Commercial Distribution

  • M556MLB8IMP1 ()
  • 10381780031598 ()
MLB8IMP

  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Reduction Polyaxial Screw, Ø5.5 x 40mm
Seaspine, Inc.
62-5540
Not in Commercial Distribution

  • M5566255401 ()
  • 10381780031482 ()

  • Ø5.5 x 40mm
62-5540

  • Bone-screw internal spinal fixation system, non-sterile
NewPort Double Lead Screw, DIA 7.5 x 95mm
Seaspine, Inc.
61-7595
Not in Commercial Distribution

  • M5566175951 ()
  • 10381780031475 ()

  • DIA 7.5 x 95mm
61-7595

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