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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 Device Size Type Device Class Implantable

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Malibu - 10889981001643

Malibu Polyaxial Screw,8.0 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
12-8065
Not in Commercial Distribution

  • 10889981001643 ()

  • 8.0 x 65mm
12-8065

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

Malibu - 10889981001636

Malibu Polyaxial Screw,8.0 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
12-8060
Not in Commercial Distribution

  • 10889981001636 ()

  • 8.0 x 60mm
12-8060

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

Malibu - 10889981001629

Malibu Polyaxial Screw,8.0 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
12-8055
Not in Commercial Distribution

  • 10889981001629 ()

  • 8.0 x 55mm
12-8055

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

Malibu - 10889981001612

Malibu Polyaxial Screw,8.0 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
12-8050
Not in Commercial Distribution

  • 10889981001612 ()

  • 8.0 x 50mm
12-8050

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

Malibu - 10889981001605

Malibu Polyaxial Screw,8.0 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
12-8045
Not in Commercial Distribution

  • 10889981001605 ()

  • 8.0 x 45mm
12-8045

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

Malibu - 10889981001599

Malibu Polyaxial Screw,8.0 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
12-8040
Not in Commercial Distribution

  • 10889981001599 ()

  • 8.0 x 40mm
12-8040

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

Malibu - 10889981001582

Malibu Polyaxial Screw,8.0 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
12-8035
Not in Commercial Distribution

  • 10889981001582 ()

  • 8.0 x 35mm
12-8035

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

Malibu - 10889981001575

Malibu Polyaxial Screw,8.0 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
12-8030
Not in Commercial Distribution

  • 10889981001575 ()

  • 8.0 x 30mm
12-8030

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

Malibu - 10889981001568

Malibu Polyaxial Screw,8.0 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
12-8010
Not in Commercial Distribution

  • 10889981001568 ()

  • 8.0 x 110mm
12-8010

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

Malibu - 10889981001551

Malibu Polyaxial Screw,8.0 x 105mm
SEASPINE ORTHOPEDICS CORPORATION
12-8005
Not in Commercial Distribution

  • 10889981001551 ()

  • 8.0 x 105mm
12-8005

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

Malibu - 10889981001544

Malibu Polyaxial Screw,8.0 x 100mm
SEASPINE ORTHOPEDICS CORPORATION
12-8000
Not in Commercial Distribution

  • 10889981001544 ()

  • 8.0 x 100mm
12-8000

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

Malibu - 10889981001537

Malibu Polyaxial Screw,7.5 x 95mm
SEASPINE ORTHOPEDICS CORPORATION
12-7595
Not in Commercial Distribution

  • 10889981001537 ()

  • 7.5 x 95mm
12-7595

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

Malibu - 10889981001520

Malibu Polyaxial Screw,7.5 x 90mm
SEASPINE ORTHOPEDICS CORPORATION
12-7590
Not in Commercial Distribution

  • 10889981001520 ()

  • 7.5 x 90mm
12-7590

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

Malibu - 10889981001513

Malibu Polyaxial Screw,7.5 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
12-7585
Not in Commercial Distribution

  • 10889981001513 ()

  • 7.5 x 85mm
12-7585

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

Malibu - 10889981001506

Malibu Polyaxial Screw,7.5 x 80mm
SEASPINE ORTHOPEDICS CORPORATION
12-7580
In Commercial Distribution

  • 10889981001506 ()

  • 7.5 x 80mm
12-7580

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

Malibu - 10889981001490

Malibu Polyaxial Screw,7.5 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
12-7575
Not in Commercial Distribution

  • 10889981001490 ()

  • 7.5 x 75mm
12-7575

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

Malibu - 10889981001483

Malibu Polyaxial Screw,7.5 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
12-7570
In Commercial Distribution

  • 10889981001483 ()

  • 7.5 x 70mm
12-7570

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

Malibu - 10889981001476

Malibu Polyaxial Screw,7.5 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
12-7565
Not in Commercial Distribution

  • 10889981001476 ()

  • 7.5 x 65mm
12-7565

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

Malibu - 10889981001469

Malibu Polyaxial Screw,7.5 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
12-7560
In Commercial Distribution

  • 10889981001469 ()

  • 7.5 x 60mm
12-7560

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

Malibu - 10889981001452

Malibu Polyaxial Screw,7.5 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
12-7555
In Commercial Distribution

  • 10889981001452 ()

  • 7.5 x 55mm
12-7555

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

Malibu - 10889981001445

Malibu Polyaxial Screw,7.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
12-7550
In Commercial Distribution

  • 10889981001445 ()

  • 7.5 x 50mm
12-7550

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

Malibu - 10889981001438

Malibu Polyaxial Screw,7.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
12-7545
In Commercial Distribution

  • 10889981001438 ()

  • 7.5 x 45mm
12-7545

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

Malibu - 10889981001421

Malibu Polyaxial Screw,7.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
12-7540
In Commercial Distribution

  • 10889981001421 ()

  • 7.5 x 40mm
12-7540

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

Malibu - 10889981001414

Malibu Polyaxial Screw,7.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
12-7535
In Commercial Distribution

  • 10889981001414 ()

  • 7.5 x 35mm
12-7535

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

Malibu - 10889981001407

Malibu Polyaxial Screw,7.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
12-7530
In Commercial Distribution

  • 10889981001407 ()

  • 7.5 x 30mm
12-7530

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

Malibu - 10889981001391

Malibu Polyaxial Screw,7.5 x 25mm
SEASPINE ORTHOPEDICS CORPORATION
12-7525
Not in Commercial Distribution

  • 10889981001391 ()

  • 7.5 x 25mm
12-7525

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

Malibu - 10889981001384

Malibu Polyaxial Screw,7.5 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
12-7510
Not in Commercial Distribution

  • 10889981001384 ()

  • 7.5 x 110mm
12-7510

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

Malibu - 10889981001377

Malibu Polyaxial Screw,7.5 x 105mm
SEASPINE ORTHOPEDICS CORPORATION
12-7505
Not in Commercial Distribution

  • 10889981001377 ()

  • 7.5 x 105mm
12-7505

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

Malibu - 10889981001360

Malibu Polyaxial Screw,7.5 x 100mm
SEASPINE ORTHOPEDICS CORPORATION
12-7500
Not in Commercial Distribution

  • 10889981001360 ()

  • 7.5 x 100mm
12-7500

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

Malibu - 10889981001353

Malibu Polyaxial Screw,7.0 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
12-7070
Not in Commercial Distribution

  • 10889981001353 ()

  • 7.0 x 70mm
12-7070

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

Malibu - 10889981001346

Malibu Polyaxial Screw,7.0 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
12-7065
Not in Commercial Distribution

  • 10889981001346 ()

  • 7.0 x 65mm
12-7065

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

Malibu - 10889981000837

Malibu Polyaxial Screw, 4.5 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
12-4560
Not in Commercial Distribution

  • 10889981000837 ()

  • 4.5 x 60mm
12-4560

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

Malibu - 10889981000820

Malibu Polyaxial Screw, 4.5 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
12-4555
Not in Commercial Distribution

  • 10889981000820 ()

  • 4.5 x 55mm
12-4555

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

Malibu - 10889981000806

Malibu Polyaxial Screw,4.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
12-4545
In Commercial Distribution

  • 10889981000806 ()

  • 4.5 x 45mm
12-4545

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

Malibu - 10889981000776

Malibu Polyaxial Screw,4.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
12-4530
In Commercial Distribution

  • 10889981000776 ()

  • 4.5 x 30mm
12-4530

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

Malibu - 10889981000752

Malibu Polyaxial Screw,4.5 x 20mm
SEASPINE ORTHOPEDICS CORPORATION
12-4520
In Commercial Distribution

  • 10889981000752 ()

  • 4.5 x 20mm
12-4520

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

Malibu - 10889981000738

LOCKING CAP
SEASPINE ORTHOPEDICS CORPORATION
12-0010
In Commercial Distribution

  • 10889981000738 ()
12-0010

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

UCR - 10889981000721

Polyaxial Reduction Screw 8.0 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
11-8060
In Commercial Distribution

  • 10889981000721 ()

  • 8.0 x 60mm
11-8060

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

UCR - 10889981000714

Polyaxial Reduction Screw 8.0 x 55mm
SEASPINE ORTHOPEDICS CORPORATION
11-8055
In Commercial Distribution

  • 10889981000714 ()

  • 8.0 x 55mm
11-8055

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

UCR - 10889981000707

Polyaxial Reduction Screw 8.0 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
11-8050
In Commercial Distribution

  • 10889981000707 ()

  • 8.0 x 50mm
11-8050

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

UCR - 10889981000691

Polyaxial Reduction Screw 8.0 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
11-8045
In Commercial Distribution

  • 10889981000691 ()

  • 8.0 x 45mm
11-8045

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

UCR - 10889981000684

Polyaxial Reduction Screw 8.0 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
11-8040
In Commercial Distribution

  • 10889981000684 ()

  • 8.0 x 40mm
11-8040

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

UCR - 10889981000677

Polyaxial Reduction Screw 8.0 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
11-8035
In Commercial Distribution

  • 10889981000677 ()

  • 8.0 x 35mm
11-8035

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

UCR - 10889981000660

Polyaxial Reduction Screw 8.0 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
11-8030
In Commercial Distribution

  • 10889981000660 ()

  • 8.0 x 30mm
11-8030

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

UCR - 10889981000653

Polyaxial Reduction Screw 6.75 x 60 mm
SEASPINE ORTHOPEDICS CORPORATION
11-6760
In Commercial Distribution

  • 10889981000653 ()

  • 6.75 x 60 mm
11-6760

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

UCR - 10889981000646

Polyaxial Reduction Screw 6.75 x 55 mm
SEASPINE ORTHOPEDICS CORPORATION
11-6755
In Commercial Distribution

  • 10889981000646 ()

  • 6.75 x 55 mm
11-6755

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

UCR - 10889981000639

Polyaxial Reduction Screw 6.75 x 50 mm
SEASPINE ORTHOPEDICS CORPORATION
11-6750
In Commercial Distribution

  • 10889981000639 ()

  • 6.75 x 50 mm
11-6750

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

UCR - 10889981000622

Polyaxial Reduction Screw 6.75 x 45 mm
SEASPINE ORTHOPEDICS CORPORATION
11-6745
In Commercial Distribution

  • 10889981000622 ()

  • 6.75 x 45 mm
11-6745

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

UCR - 10889981000615

Polyaxial Reduction Screw 6.75 x 40 mm
SEASPINE ORTHOPEDICS CORPORATION
11-6740
In Commercial Distribution

  • 10889981000615 ()

  • 6.75 x 40 mm
11-6740

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

UCR - 10889981000608

Polyaxial Reduction Screw 6.75 x 35 mm
SEASPINE ORTHOPEDICS CORPORATION
11-6735
In Commercial Distribution

  • 10889981000608 ()

  • 6.75 x 35 mm
11-6735

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