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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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Malibu - 10381780000990

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 - 10381780000983

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 - 10381780000976

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 - 10381780000969

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 - 10381780000952

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

UCR - 10381780000945

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

UCR - 10381780000938

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

UCR - 10381780000921

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

UCR - 10381780000914

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

UCR - 10381780000907

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
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