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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™ - 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

Newport - 10381780031444

NewPort Double Lead Screw, DIA 7.5 x 80mm
Seaspine, Inc.
61-7580
Not in Commercial Distribution

  • M5566175801 ()
  • 10381780031444 ()

  • DIA 7.5 x 80mm
61-7580

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

Newport - 10381780031437

NewPort Double Lead Screw, DIA 7.5 x 75mm
Seaspine, Inc.
61-7575
Not in Commercial Distribution

  • M5566175751 ()
  • 10381780031437 ()

  • DIA 7.5 x 75mm
61-7575

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

Newport - 10381780031420

NewPort Double Lead Screw, DIA 7.5 x 70mm
Seaspine, Inc.
61-7570
Not in Commercial Distribution

  • M5566175701 ()
  • 10381780031420 ()

  • DIA 7.5 x 70mm
61-7570

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

Newport - 10381780031413

NewPort Double Lead Screw, DIA 7.5 x 65mm
Seaspine, Inc.
61-7565
Not in Commercial Distribution

  • M5566175651 ()
  • 10381780031413 ()

  • DIA 7.5 x 65mm
61-7565

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