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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 - 10381780003748

Cannulated Polyaxial Screw, 8.5 x 80MM
Seaspine, Inc.
18-8580
Not in Commercial Distribution

  • M5561885801 ()
  • 10381780003748 ()

  • 8.5 x 80MM
18-8580

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

Malibu - 10381780003731

Cannulated Polyaxial Screw, 8.5 x 75MM
Seaspine, Inc.
18-8575
Not in Commercial Distribution

  • M5561885751 ()
  • 10381780003731 ()

  • 8.5 x 75MM
18-8575

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

Malibu - 10381780003724

Cannulated Polyaxial Screw, 8.5 x 70MM
Seaspine, Inc.
18-8570
Not in Commercial Distribution

  • M5561885701 ()
  • 10381780003724 ()

  • 8.5 x 70MM
18-8570

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

Malibu - 10381780003717

Cannulated Polyaxial Screw, 8.5 x 65MM
Seaspine, Inc.
18-8565
Not in Commercial Distribution

  • M5561885651 ()
  • 10381780003717 ()

  • 8.5 x 65MM
18-8565

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

Malibu - 10381780003700

Cannulated Polyaxial Screw, 8.5 x 60MM
Seaspine, Inc.
18-8560
Not in Commercial Distribution

  • M5561885601 ()
  • 10381780003700 ()

  • 8.5 x 60MM
18-8560

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

Malibu - 10381780003694

Cannulated Polyaxial Screw, 8.5 x 55MM
Seaspine, Inc.
18-8555
Not in Commercial Distribution

  • M5561885551 ()
  • 10381780003694 ()

  • 8.5 x 55MM
18-8555

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

Malibu - 10381780003687

Cannulated Polyaxial Screw, 8.5 x 50MM
Seaspine, Inc.
18-8550
Not in Commercial Distribution

  • M5561885501 ()
  • 10381780003687 ()

  • 8.5 x 50MM
18-8550

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

Malibu - 10381780003670

Cannulated Polyaxial Screw, 8.5 x 45MM
Seaspine, Inc.
18-8545
Not in Commercial Distribution

  • M5561885451 ()
  • 10381780003670 ()

  • 8.5 x 45MM
18-8545

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

Malibu - 10381780003663

Cannulated Polyaxial Screw, 8.5 x 40MM
Seaspine, Inc.
18-8540
Not in Commercial Distribution

  • M5561885401 ()
  • 10381780003663 ()

  • 8.5 x 40MM
18-8540

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

Malibu - 10381780003656

Cannulated Polyaxial Screw, 8.5 x 35MM
Seaspine, Inc.
18-8535
Not in Commercial Distribution

  • M5561885351 ()
  • 10381780003656 ()

  • 8.5 x 35MM
18-8535

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