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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 - 10381780002130

Malibu Polyaxial Reduction Screw,8.0 x 55mm
Seaspine, Inc.
13-8055
Not in Commercial Distribution

  • M5561380551 ()
  • 10381780002130 ()

  • 8.0 x 55mm
13-8055

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

Malibu - 10381780002123

Malibu Polyaxial Reduction Screw,8.0 x 50mm
Seaspine, Inc.
13-8050
Not in Commercial Distribution

  • M5561380501 ()
  • 10381780002123 ()

  • 8.0 x 50mm
13-8050

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

Malibu - 10381780002116

Malibu Polyaxial Reduction Screw,8.0 x 45mm
Seaspine, Inc.
13-8045
Not in Commercial Distribution

  • M5561380451 ()
  • 10381780002116 ()

  • 8.0 x 45mm
13-8045

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

Malibu - 10381780002109

Malibu Polyaxial Reduction Screw,8.0 x 40mm
Seaspine, Inc.
13-8040
Not in Commercial Distribution

  • M5561380401 ()
  • 10381780002109 ()

  • 8.0 x 40mm
13-8040

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

Malibu™ - 10381780031604

Malibu Deformity Implant
Seaspine, Inc.
MLBDFIMP
Not in Commercial Distribution

  • M556MLBDFIMP1 ()
  • 10381780031604 ()
MLBDFIMP

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

Malibu™ - 10381780031598

Malibu 8.0 Implant
Seaspine, Inc.
MLB8IMP
Not in Commercial Distribution

  • M556MLB8IMP1 ()
  • 10381780031598 ()
MLB8IMP

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

Newport - 10381780031482

Cannulated Reduction Polyaxial Screw, Ø5.5 x 40mm
Seaspine, Inc.
62-5540
Not in Commercial Distribution

  • M5566255401 ()
  • 10381780031482 ()

  • Ø5.5 x 40mm
62-5540

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

Newport - 10381780031475

NewPort Double Lead Screw, DIA 7.5 x 95mm
Seaspine, Inc.
61-7595
Not in Commercial Distribution

  • M5566175951 ()
  • 10381780031475 ()

  • DIA 7.5 x 95mm
61-7595

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

Newport - 10381780031468

NewPort Double Lead Screw, DIA 7.5 x 90mm
Seaspine, Inc.
61-7590
Not in Commercial Distribution

  • M5566175901 ()
  • 10381780031468 ()

  • DIA 7.5 x 90mm
61-7590

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

Newport - 10381780031451

NewPort Double Lead Screw, DIA 7.5 x 85mm
Seaspine, Inc.
61-7585
Not in Commercial Distribution

  • M5566175851 ()
  • 10381780031451 ()

  • DIA 7.5 x 85mm
61-7585

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