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 DLTA SCREW,4.5 X 50
Seaspine, Inc.
69-4550
Not in Commercial Distribution

  • M5566945501 ()
  • 10381780005056 ()

  • 4.5 X 50
69-4550

  • Bone-screw internal spinal fixation system, non-sterile
UNI-PLANAR DLTA SCREW,4.5 X 45
Seaspine, Inc.
69-4545
Not in Commercial Distribution

  • M5566945451 ()
  • 10381780005049 ()

  • 4.5 X 45
69-4545

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 4.5 DIA x 45mm
Seaspine, Inc.
67-4545
Not in Commercial Distribution

  • M5566745451 ()
  • 10381780005032 ()

  • 4.5 DIA x 45mm
67-4545

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 4.5 DIA x 40mm
Seaspine, Inc.
67-4540
Not in Commercial Distribution

  • M5566745401 ()
  • 10381780005025 ()

  • 4.5 DIA x 40mm
67-4540

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 4.5 DIA x 35mm
Seaspine, Inc.
67-4535
Not in Commercial Distribution

  • M5566745351 ()
  • 10381780005018 ()

  • 4.5 DIA x 35mm
67-4535

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 4.5 DIA x 30mm
Seaspine, Inc.
67-4530
Not in Commercial Distribution

  • M5566745301 ()
  • 10381780005001 ()

  • 4.5 DIA x 30mm
67-4530

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 4.5 DIA x 25mm
Seaspine, Inc.
67-4525
Not in Commercial Distribution

  • M5566745251 ()
  • 10381780004998 ()

  • 4.5 DIA x 25mm
67-4525

  • Bone-screw internal spinal fixation system, non-sterile
Uni-Planar Screw, 4.5 DIA x 20mm
Seaspine, Inc.
67-4520
Not in Commercial Distribution

  • M5566745201 ()
  • 10381780004981 ()

  • 4.5 DIA x 20mm
67-4520

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 35mm
Seaspine, Inc.
13-8035
Not in Commercial Distribution

  • M5561380351 ()
  • 10381780002093 ()

  • 8.0 x 35mm
13-8035

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 30mm
Seaspine, Inc.
13-8030
Not in Commercial Distribution

  • M5561380301 ()
  • 10381780002086 ()

  • 8.0 x 30mm
13-8030

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 110mm
Seaspine, Inc.
13-8010
Not in Commercial Distribution

  • M5561380101 ()
  • 10381780002079 ()

  • 8.0 x 110mm
13-8010

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 105mm
Seaspine, Inc.
13-8005
Not in Commercial Distribution

  • M5561380051 ()
  • 10381780002062 ()

  • 8.0 x 105mm
13-8005

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,8.0 x 100mm
Seaspine, Inc.
13-8000
Not in Commercial Distribution

  • M5561380001 ()
  • 10381780002055 ()

  • 8.0 x 100mm
13-8000

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 95mm
Seaspine, Inc.
13-7595
Not in Commercial Distribution

  • M5561375951 ()
  • 10381780002048 ()

  • 7.5 x 95mm
13-7595

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 90mm
Seaspine, Inc.
13-7590
Not in Commercial Distribution

  • M5561375901 ()
  • 10381780002031 ()

  • 7.5 x 90mm
13-7590

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 85mm
Seaspine, Inc.
13-7585
Not in Commercial Distribution

  • M5561375851 ()
  • 10381780002024 ()

  • 7.5 x 85mm
13-7585

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 80mm
Seaspine, Inc.
13-7580
Not in Commercial Distribution

  • M5561375801 ()
  • 10381780002017 ()

  • 7.5 x 80mm
13-7580

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 75mm
Seaspine, Inc.
13-7575
Not in Commercial Distribution

  • M5561375751 ()
  • 10381780002000 ()

  • 7.5 x 75mm
13-7575

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 70mm
Seaspine, Inc.
13-7570
Not in Commercial Distribution

  • M5561375701 ()
  • 10381780001997 ()

  • 7.5 x 70mm
13-7570

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 65mm
Seaspine, Inc.
13-7565
Not in Commercial Distribution

  • M5561375651 ()
  • 10381780001980 ()

  • 7.5 x 65mm
13-7565

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 60mm
Seaspine, Inc.
13-7560
Not in Commercial Distribution

  • M5561375601 ()
  • 10381780001973 ()

  • 7.5 x 60mm
13-7560

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 30mm
Seaspine, Inc.
13-7530
Not in Commercial Distribution

  • M5561375301 ()
  • 10381780001966 ()

  • 7.5 x 30mm
13-7530

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 25mm
Seaspine, Inc.
13-7525
Not in Commercial Distribution

  • M5561375251 ()
  • 10381780001959 ()

  • 7.5 x 25mm
13-7525

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 110mm
Seaspine, Inc.
13-7510
Not in Commercial Distribution

  • M5561375101 ()
  • 10381780001942 ()

  • 7.5 x 110mm
13-7510

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 105mm
Seaspine, Inc.
13-7505
Not in Commercial Distribution

  • M5561375051 ()
  • 10381780001935 ()

  • 7.5 x 105mm
13-7505

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 100mm
Seaspine, Inc.
13-7500
Not in Commercial Distribution

  • M5561375001 ()
  • 10381780001928 ()

  • 7.5 x 100mm
13-7500

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.0 x 70mm
Seaspine, Inc.
13-7070
Not in Commercial Distribution

  • M5561370701 ()
  • 10381780001911 ()

  • 7.0 x 70mm
13-7070

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.0 x 65mm
Seaspine, Inc.
13-7065
Not in Commercial Distribution

  • M5561370651 ()
  • 10381780001904 ()

  • 7.0 x 65mm
13-7065

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.0 x 60mm
Seaspine, Inc.
13-7060
Not in Commercial Distribution

  • M5561370601 ()
  • 10381780001898 ()

  • 7.0 x 60mm
13-7060

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.0 x 55mm
Seaspine, Inc.
13-7055
Not in Commercial Distribution

  • M5561370551 ()
  • 10381780001881 ()

  • 7.0 x 55mm
13-7055

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.0 x 50mm
Seaspine, Inc.
13-7050
Not in Commercial Distribution

  • M5561370501 ()
  • 10381780001874 ()

  • 7.0 x 50mm
13-7050

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.0 x 45mm
Seaspine, Inc.
13-7045
Not in Commercial Distribution

  • M5561370451 ()
  • 10381780001867 ()

  • 7.0 x 45mm
13-7045

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.0 x 40mm
Seaspine, Inc.
13-7040
Not in Commercial Distribution

  • M5561370401 ()
  • 10381780001850 ()

  • 7.0 x 40mm
13-7040

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.0 x 35mm
Seaspine, Inc.
13-7035
Not in Commercial Distribution

  • M5561370351 ()
  • 10381780001843 ()

  • 7.0 x 35mm
13-7035

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.0 x 30mm
Seaspine, Inc.
13-7030
Not in Commercial Distribution

  • M5561370301 ()
  • 10381780001836 ()

  • 7.0 x 30mm
13-7030

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.0 x 25mm
Seaspine, Inc.
13-7025
Not in Commercial Distribution

  • M5561370251 ()
  • 10381780001829 ()

  • 7.0 x 25mm
13-7025

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,6.5 x 95mm
Seaspine, Inc.
13-6595
Not in Commercial Distribution

  • M5561365951 ()
  • 10381780001812 ()

  • 6.5 x 95mm
13-6595

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,6.5 x 90mm
Seaspine, Inc.
13-6590
Not in Commercial Distribution

  • M5561365901 ()
  • 10381780001805 ()

  • 6.5 x 90mm
13-6590

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,6.5 x 85mm
Seaspine, Inc.
13-6585
Not in Commercial Distribution

  • M5561365851 ()
  • 10381780001799 ()

  • 6.5 x 85mm
13-6585

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,6.5 x 80mm
Seaspine, Inc.
13-6580
Not in Commercial Distribution

  • M5561365801 ()
  • 10381780001782 ()

  • 6.5 x 80mm
13-6580

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