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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Monoaxial Screw, 5.5 x 40mm
Seaspine, Inc.
16-5540
Not in Commercial Distribution

  • M5561655401 ()
  • 10381780013167 ()

  • 5.5 x 40mm
16-5540

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 5.5 x 35mm
Seaspine, Inc.
16-5535
Not in Commercial Distribution

  • M5561655351 ()
  • 10381780013150 ()

  • 5.5 x 35mm
16-5535

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 5.5 x 30mm
Seaspine, Inc.
16-5530
Not in Commercial Distribution

  • M5561655301 ()
  • 10381780013143 ()

  • 5.5 x 30mm
16-5530

  • Bone-screw internal spinal fixation system, non-sterile
Monoaxial Screw, 4.5 x 40mm
Seaspine, Inc.
16-4540
Not in Commercial Distribution

  • M5561645401 ()
  • 10381780013136 ()

  • 4.5 x 40mm
16-4540

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Set Screw
Seaspine, Inc.
16-0015
Not in Commercial Distribution

  • M5561600151 ()
  • 10381780013129 ()
16-0015

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL LOCKING CAP
Seaspine, Inc.
16-0010
Not in Commercial Distribution

  • M5561600101 ()
  • 10381780013105 ()
16-0010

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 55mm
Seaspine, Inc.
13-7555
Not in Commercial Distribution

  • M5561375551 ()
  • 10381780013075 ()

  • 7.5 x 55mm
13-7555

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 50mm
Seaspine, Inc.
13-7550
Not in Commercial Distribution

  • M5561375501 ()
  • 10381780013068 ()

  • 7.5 x 50mm
13-7550

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 45mm
Seaspine, Inc.
13-7545
Not in Commercial Distribution

  • M5561375451 ()
  • 10381780013051 ()

  • 7.5 x 45mm
13-7545

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Polyaxial Reduction Screw,7.5 x 40mm
Seaspine, Inc.
13-7540
Not in Commercial Distribution

  • M5561375401 ()
  • 10381780013044 ()

  • 7.5 x 40mm
13-7540

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