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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 - 10381780022640

Uni-Planar Reduction Screw, 6.5 DIA x 80mm
Seaspine, Inc.
68-6580
Not in Commercial Distribution

  • M5566865801 ()
  • 10381780022640 ()

  • 6.5 DIA x 80mm
68-6580

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

Malibu - 10381780022633

Uni-Planar Reduction Screw, 6.5 DIA x 75mm
Seaspine, Inc.
68-6575
Not in Commercial Distribution

  • M5566865751 ()
  • 10381780022633 ()

  • 6.5 DIA x 75mm
68-6575

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

Malibu - 10381780022626

Uni-Planar Reduction Screw, 6.5 DIA x 70mm
Seaspine, Inc.
68-6570
Not in Commercial Distribution

  • M5566865701 ()
  • 10381780022626 ()

  • 6.5 DIA x 70mm
68-6570

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

Malibu - 10381780022619

Uni-Planar Reduction Screw, 6.5 DIA x 65mm
Seaspine, Inc.
68-6565
Not in Commercial Distribution

  • M5566865651 ()
  • 10381780022619 ()

  • 6.5 DIA x 65mm
68-6565

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

Malibu - 10381780022602

Uni-Planar Reduction Screw, 6.5 DIA x 60mm
Seaspine, Inc.
68-6560
Not in Commercial Distribution

  • M5566865601 ()
  • 10381780022602 ()

  • 6.5 DIA x 60mm
68-6560

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

Malibu - 10381780022596

Uni-Planar Reduction Screw, 6.5 DIA x 55mm
Seaspine, Inc.
68-6555
Not in Commercial Distribution

  • M5566865551 ()
  • 10381780022596 ()

  • 6.5 DIA x 55mm
68-6555

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

Malibu - 10381780022589

Uni-Planar Reduction Screw, 6.5 DIA x 50mm
Seaspine, Inc.
68-6550
Not in Commercial Distribution

  • M5566865501 ()
  • 10381780022589 ()

  • 6.5 DIA x 50mm
68-6550

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

Malibu - 10381780022572

Uni-Planar Reduction Screw, 6.5 DIA x 45mm
Seaspine, Inc.
68-6545
Not in Commercial Distribution

  • M5566865451 ()
  • 10381780022572 ()

  • 6.5 DIA x 45mm
68-6545

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

Malibu - 10381780022565

Uni-Planar Reduction Screw, 6.5 DIA x 40mm
Seaspine, Inc.
68-6540
Not in Commercial Distribution

  • M5566865401 ()
  • 10381780022565 ()

  • 6.5 DIA x 40mm
68-6540

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

Malibu - 10381780022558

Uni-Planar Reduction Screw, 6.5 DIA x 35mm
Seaspine, Inc.
68-6535
Not in Commercial Distribution

  • M5566865351 ()
  • 10381780022558 ()

  • 6.5 DIA x 35mm
68-6535

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

Malibu - 10381780022541

Uni-Planar Reduction Screw, 6.5 DIA x 30mm
Seaspine, Inc.
68-6530
Not in Commercial Distribution

  • M5566865301 ()
  • 10381780022541 ()

  • 6.5 DIA x 30mm
68-6530

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

Malibu - 10381780022534

Uni-Planar Reduction Screw, 6.5 DIA x 25mm
Seaspine, Inc.
68-6525
Not in Commercial Distribution

  • M5566865251 ()
  • 10381780022534 ()

  • 6.5 DIA x 25mm
68-6525

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

Malibu - 10381780022527

Uni-Planar Reduction Screw, 6.5 DIA x 110mm
Seaspine, Inc.
68-6510
Not in Commercial Distribution

  • M5566865101 ()
  • 10381780022527 ()

  • 6.5 DIA x 110mm
68-6510

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

Malibu - 10381780022510

Uni-Planar Reduction Screw, 6.5 DIA x 105mm
Seaspine, Inc.
68-6505
Not in Commercial Distribution

  • M5566865051 ()
  • 10381780022510 ()

  • 6.5 DIA x 105mm
68-6505

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

Malibu - 10381780022503

Uni-Planar Reduction Screw, 6.5 DIA x 100mm
Seaspine, Inc.
68-6500
Not in Commercial Distribution

  • M5566865001 ()
  • 10381780022503 ()

  • 6.5 DIA x 100mm
68-6500

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

Malibu - 10381780022497

Uni-Planar Reduction Screw, 6.0 DIA x 60mm
Seaspine, Inc.
68-6060
Not in Commercial Distribution

  • M5566860601 ()
  • 10381780022497 ()

  • 6.0 DIA x 60mm
68-6060

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

Malibu - 10381780022480

Uni-Planar Reduction Screw, 6.0 DIA x 55mm
Seaspine, Inc.
68-6055
Not in Commercial Distribution

  • M5566860551 ()
  • 10381780022480 ()

  • 6.0 DIA x 55mm
68-6055

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

Malibu - 10381780022473

Uni-Planar Reduction Screw, 6.0 DIA x 50mm
Seaspine, Inc.
68-6050
Not in Commercial Distribution

  • M5566860501 ()
  • 10381780022473 ()

  • 6.0 DIA x 50mm
68-6050

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

Malibu - 10381780022466

Uni-Planar Reduction Screw, 6.0 DIA x 45mm
Seaspine, Inc.
68-6045
Not in Commercial Distribution

  • M5566860451 ()
  • 10381780022466 ()

  • 6.0 DIA x 45mm
68-6045

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

Malibu - 10381780022459

Uni-Planar Reduction Screw, 6.0 DIA x 40mm
Seaspine, Inc.
68-6040
Not in Commercial Distribution

  • M5566860401 ()
  • 10381780022459 ()

  • 6.0 DIA x 40mm
68-6040

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

Malibu - 10381780022442

Uni-Planar Reduction Screw, 6.0 DIA x 35mm
Seaspine, Inc.
68-6035
Not in Commercial Distribution

  • M5566860351 ()
  • 10381780022442 ()

  • 6.0 DIA x 35mm
68-6035

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

Malibu - 10381780022435

Uni-Planar Reduction Screw, 6.0 DIA x 30mm
Seaspine, Inc.
68-6030
Not in Commercial Distribution

  • M5566860301 ()
  • 10381780022435 ()

  • 6.0 DIA x 30mm
68-6030

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

Malibu - 10381780022428

Uni-Planar Reduction Screw, 6.0 DIA x 25mm
Seaspine, Inc.
68-6025
Not in Commercial Distribution

  • M5566860251 ()
  • 10381780022428 ()

  • 6.0 DIA x 25mm
68-6025

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

Malibu - 10381780022411

Uni-Planar Reduction Screw, 5.5 DIA x 60mm
Seaspine, Inc.
68-5560
Not in Commercial Distribution

  • M5566855601 ()
  • 10381780022411 ()

  • 5.5 DIA x 60mm
68-5560

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

Malibu - 10381780022404

Uni-Planar Reduction Screw, 5.5 DIA x 55mm
Seaspine, Inc.
68-5555
Not in Commercial Distribution

  • M5566855551 ()
  • 10381780022404 ()

  • 5.5 DIA x 55mm
68-5555

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

Malibu - 10381780022398

Uni-Planar Reduction Screw, 5.5 DIA x 50mm
Seaspine, Inc.
68-5550
Not in Commercial Distribution

  • M5566855501 ()
  • 10381780022398 ()

  • 5.5 DIA x 50mm
68-5550

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

Malibu - 10381780022381

Uni-Planar Reduction Screw, 5.5 DIA x 45mm
Seaspine, Inc.
68-5545
Not in Commercial Distribution

  • M5566855451 ()
  • 10381780022381 ()

  • 5.5 DIA x 45mm
68-5545

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

Malibu - 10381780022374

Uni-Planar Reduction Screw, 5.5 DIA x 40mm
Seaspine, Inc.
68-5540
Not in Commercial Distribution

  • M5566855401 ()
  • 10381780022374 ()

  • 5.5 DIA x 40mm
68-5540

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

Malibu - 10381780022367

Uni-Planar Reduction Screw, 5.5 DIA x 35mm
Seaspine, Inc.
68-5535
Not in Commercial Distribution

  • M5566855351 ()
  • 10381780022367 ()

  • 5.5 DIA x 35mm
68-5535

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

Malibu - 10381780022350

Uni-Planar Reduction Screw, 5.5 DIA x 30mm
Seaspine, Inc.
68-5530
Not in Commercial Distribution

  • M5566855301 ()
  • 10381780022350 ()

  • 5.5 DIA x 30mm
68-5530

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

Malibu - 10381780022343

Uni-Planar Reduction Screw, 5.5 DIA x 25mm
Seaspine, Inc.
68-5525
Not in Commercial Distribution

  • M5566855251 ()
  • 10381780022343 ()

  • 5.5 DIA x 25mm
68-5525

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

Malibu - 10381780022336

Uni-Planar Reduction Screw, 5.0 DIA x 60mm
Seaspine, Inc.
68-5060
Not in Commercial Distribution

  • M5566850601 ()
  • 10381780022336 ()

  • 5.0 DIA x 60mm
68-5060

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

Malibu - 10381780022329

Uni-Planar Reduction Screw, 5.0 DIA x 55mm
Seaspine, Inc.
68-5055
Not in Commercial Distribution

  • M5566850551 ()
  • 10381780022329 ()

  • 5.0 DIA x 55mm
68-5055

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

Malibu - 10381780022312

Uni-Planar Reduction Screw, 5.0 DIA x 50mm
Seaspine, Inc.
68-5050
Not in Commercial Distribution

  • M5566850501 ()
  • 10381780022312 ()

  • 5.0 DIA x 50mm
68-5050

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

Malibu - 10381780022305

Uni-Planar Reduction Screw, 5.0 DIA x 45mm
Seaspine, Inc.
68-5045
Not in Commercial Distribution

  • M5566850451 ()
  • 10381780022305 ()

  • 5.0 DIA x 45mm
68-5045

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

Malibu - 10381780022299

Uni-Planar Reduction Screw, 5.0 DIA x 40mm
Seaspine, Inc.
68-5040
Not in Commercial Distribution

  • M5566850401 ()
  • 10381780022299 ()

  • 5.0 DIA x 40mm
68-5040

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

Malibu - 10381780022282

Uni-Planar Reduction Screw, 5.0 DIA x 35mm
Seaspine, Inc.
68-5035
Not in Commercial Distribution

  • M5566850351 ()
  • 10381780022282 ()

  • 5.0 DIA x 35mm
68-5035

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

Malibu - 10381780022275

Uni-Planar Reduction Screw, 5.0 DIA x 30mm
Seaspine, Inc.
68-5030
Not in Commercial Distribution

  • M5566850301 ()
  • 10381780022275 ()

  • 5.0 DIA x 30mm
68-5030

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

Malibu - 10381780022268

Uni-Planar Reduction Screw, 5.0 DIA x 25mm
Seaspine, Inc.
68-5025
Not in Commercial Distribution

  • M5566850251 ()
  • 10381780022268 ()

  • 5.0 DIA x 25mm
68-5025

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

Malibu - 10381780022251

Uni-Planar Reduction Screw, 4.5 DIA x 60mm
Seaspine, Inc.
68-4560
Not in Commercial Distribution

  • M5566845601 ()
  • 10381780022251 ()

  • 4.5 DIA x 60mm
68-4560

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