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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 - 10381780012283

Malibu Polyaxial Screw,4.5 x 35mm
Seaspine, Inc.
12-4535
Not in Commercial Distribution

  • M5561245351 ()
  • 10381780012283 ()

  • 4.5 x 35mm
12-4535

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

Malibu - 10381780012276

Malibu Polyaxial Screw,4.5 x 30mm
Seaspine, Inc.
12-4530
Not in Commercial Distribution

  • M5561245301 ()
  • 10381780012276 ()

  • 4.5 x 30mm
12-4530

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

Malibu - 10381780012269

Malibu Polyaxial Screw,4.5 x 25mm
Seaspine, Inc.
12-4525
Not in Commercial Distribution

  • M5561245251 ()
  • 10381780012269 ()

  • 4.5 x 25mm
12-4525

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

Malibu - 10381780012252

Malibu Polyaxial Screw,4.5 x 20mm
Seaspine, Inc.
12-4520
Not in Commercial Distribution

  • M5561245201 ()
  • 10381780012252 ()

  • 4.5 x 20mm
12-4520

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

Malibu - 10381780012245

Locking Cap, 8.0
Seaspine, Inc.
12-0020
Not in Commercial Distribution

  • M5561200201 ()
  • 10381780012245 ()

  • 8
12-0020

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

Malibu - 10381780012238

LOCKING CAP
Seaspine, Inc.
12-0010
Not in Commercial Distribution

  • M5561200101 ()
  • 10381780012238 ()

  • None
12-0010

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

UCR - 10381780012221

Polyaxial Reduction Screw 8.0 x 50mm
Seaspine, Inc.
11-8050
Not in Commercial Distribution

  • M5561180501 ()
  • 10381780012221 ()

  • 8.0 x 50mm
11-8050

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

UCR - 10381780012214

Polyaxial Reduction Screw 8.0 x 45mm
Seaspine, Inc.
11-8045
Not in Commercial Distribution

  • M5561180451 ()
  • 10381780012214 ()

  • 8.0 x 45mm
11-8045

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

UCR - 10381780012207

Polyaxial Reduction Screw 8.0 x 40mm
Seaspine, Inc.
11-8040
Not in Commercial Distribution

  • M5561180401 ()
  • 10381780012207 ()

  • 8.0 x 40mm
11-8040

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

UCR - 10381780012191

Polyaxial Reduction Screw 6.75 x 55 mm
Seaspine, Inc.
11-6755
Not in Commercial Distribution

  • M5561167551 ()
  • 10381780012191 ()

  • 6.75 x 55 mm
11-6755

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