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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 - 10889981011864

Cannulated Uni-Planar Screw 7.5 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
73-7545
Not in Commercial Distribution

  • 10889981011864 ()

  • 7.5 DIA x 45mm
73-7545

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

Malibu - 10889981011857

Cannulated Uni-Planar Screw 7.5 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
73-7540
Not in Commercial Distribution

  • 10889981011857 ()

  • 7.5 DIA x 40mm
73-7540

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

Malibu - 10889981011840

Cannulated Uni-Planar Screw 7.5 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
73-7535
Not in Commercial Distribution

  • 10889981011840 ()

  • 7.5 DIA x 35mm
73-7535

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

Malibu - 10889981011833

Cannulated Uni-Planar Screw 7.5 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
73-7530
Not in Commercial Distribution

  • 10889981011833 ()

  • 7.5 DIA x 30mm
73-7530

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

Malibu - 10889981011826

Cannulated Uni-Planar Screw 7.5 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
73-7525
Not in Commercial Distribution

  • 10889981011826 ()

  • 7.5 DIA x 25mm
73-7525

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

Malibu - 10889981011819

Cannulated Uni-Planar Screw 7.0 DIA x 70mm
SEASPINE ORTHOPEDICS CORPORATION
73-7070
Not in Commercial Distribution

  • 10889981011819 ()

  • 7.0 DIA x 70mm
73-7070

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

Malibu - 10889981011802

Cannulated Uni-Planar Screw 7.0 DIA x 65mm
SEASPINE ORTHOPEDICS CORPORATION
73-7065
Not in Commercial Distribution

  • 10889981011802 ()

  • 7.0 DIA x 65mm
73-7065

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

Malibu - 10889981011796

Cannulated Uni-Planar Screw 7.0 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
73-7060
Not in Commercial Distribution

  • 10889981011796 ()

  • 7.0 DIA x 60mm
73-7060

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

Malibu - 10889981011789

Cannulated Uni-Planar Screw 7.0 DIA x 55mm
SEASPINE ORTHOPEDICS CORPORATION
73-7055
Not in Commercial Distribution

  • 10889981011789 ()

  • 7.0 DIA x 55mm
73-7055

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

Malibu - 10889981011772

Cannulated Uni-Planar Screw 7.0 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
73-7050
Not in Commercial Distribution

  • 10889981011772 ()

  • 7.0 DIA x 50mm
73-7050

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

Malibu - 10889981011765

Cannulated Uni-Planar Screw 7.0 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
73-7045
Not in Commercial Distribution

  • 10889981011765 ()

  • 7.0 DIA x 45mm
73-7045

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

Malibu - 10889981011758

Cannulated Uni-Planar Screw 7.0 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
73-7040
Not in Commercial Distribution

  • 10889981011758 ()

  • 7.0 DIA x 40mm
73-7040

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

Malibu - 10889981011741

Cannulated Uni-Planar Screw 7.0 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
73-7035
Not in Commercial Distribution

  • 10889981011741 ()

  • 7.0 DIA x 35mm
73-7035

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

Malibu - 10889981011734

Cannulated Uni-Planar Screw 7.0 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
73-7030
Not in Commercial Distribution

  • 10889981011734 ()

  • 7.0 DIA x 30mm
73-7030

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

Malibu - 10889981011727

Cannulated Uni-Planar Screw 7.0 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
73-7025
Not in Commercial Distribution

  • 10889981011727 ()

  • 7.0 DIA x 25mm
73-7025

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

Malibu - 10889981011710

Cannulated Uni-Planar Screw 6.5 DIA x 95mm
SEASPINE ORTHOPEDICS CORPORATION
73-6595
Not in Commercial Distribution

  • 10889981011710 ()

  • 6.5 DIA x 95mm
73-6595

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

Malibu - 10889981011703

Cannulated Uni-Planar Screw 6.5 DIA x 90mm
SEASPINE ORTHOPEDICS CORPORATION
73-6590
Not in Commercial Distribution

  • 10889981011703 ()

  • 6.5 DIA x 90mm
73-6590

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

Malibu - 10889981011697

Cannulated Uni-Planar Screw 6.5 DIA x 85mm
SEASPINE ORTHOPEDICS CORPORATION
73-6585
Not in Commercial Distribution

  • 10889981011697 ()

  • 6.5 DIA x 85mm
73-6585

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

Malibu - 10889981011680

Cannulated Uni-Planar Screw 6.5 DIA x 80mm
SEASPINE ORTHOPEDICS CORPORATION
73-6580
Not in Commercial Distribution

  • 10889981011680 ()

  • 6.5 DIA x 80mm
73-6580

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

Malibu - 10889981011673

Cannulated Uni-Planar Screw 6.5 DIA x 75mm
SEASPINE ORTHOPEDICS CORPORATION
73-6575
Not in Commercial Distribution

  • 10889981011673 ()

  • 6.5 DIA x 75mm
73-6575

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

Malibu - 10889981011666

Cannulated Uni-Planar Screw 6.5 DIA x 70mm
SEASPINE ORTHOPEDICS CORPORATION
73-6570
Not in Commercial Distribution

  • 10889981011666 ()

  • 6.5 DIA x 70mm
73-6570

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

Malibu - 10889981011659

Cannulated Uni-Planar Screw 6.5 DIA x 65mm
SEASPINE ORTHOPEDICS CORPORATION
73-6565
Not in Commercial Distribution

  • 10889981011659 ()

  • 6.5 DIA x 65mm
73-6565

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

Malibu - 10889981011642

Cannulated Uni-Planar Screw 6.5 DIA x 60mm
SEASPINE ORTHOPEDICS CORPORATION
73-6560
Not in Commercial Distribution

  • 10889981011642 ()

  • 6.5 DIA x 60mm
73-6560

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

Malibu - 10889981011635

Cannulated Uni-Planar Screw 6.5 DIA x 55mm
SEASPINE ORTHOPEDICS CORPORATION
73-6555
Not in Commercial Distribution

  • 10889981011635 ()

  • 6.5 DIA x 55mm
73-6555

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

Malibu - 10889981011628

Cannulated Uni-Planar Screw 6.5 DIA x 50mm
SEASPINE ORTHOPEDICS CORPORATION
73-6550
Not in Commercial Distribution

  • 10889981011628 ()

  • 6.5 DIA x 50mm
73-6550

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

Malibu - 10889981011611

Cannulated Uni-Planar Screw 6.5 DIA x 45mm
SEASPINE ORTHOPEDICS CORPORATION
73-6545
Not in Commercial Distribution

  • 10889981011611 ()

  • 6.5 DIA x 45mm
73-6545

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

Malibu - 10889981011604

Cannulated Uni-Planar Screw 6.5 DIA x 40mm
SEASPINE ORTHOPEDICS CORPORATION
73-6540
Not in Commercial Distribution

  • 10889981011604 ()

  • 6.5 DIA x 40mm
73-6540

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

Malibu - 10889981011598

Cannulated Uni-Planar Screw 6.5 DIA x 35mm
SEASPINE ORTHOPEDICS CORPORATION
73-6535
Not in Commercial Distribution

  • 10889981011598 ()

  • 6.5 DIA x 35mm
73-6535

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

Malibu - 10889981011581

Cannulated Uni-Planar Screw 6.5 DIA x 30mm
SEASPINE ORTHOPEDICS CORPORATION
73-6530
Not in Commercial Distribution

  • 10889981011581 ()

  • 6.5 DIA x 30mm
73-6530

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

Sierra™ - 10889981042691

Sierra Screw, 04.0 x 38mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4038
Not in Commercial Distribution

  • 10889981042691 ()

  • 4.0 Dia X 38mm
50-4038

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042684

Sierra Screw, 04.0 x 36mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4036
Not in Commercial Distribution

  • 10889981042684 ()

  • 4.0 Dia X 36mm
50-4036

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042677

Sierra Screw, 04.0 x 34mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4034
Not in Commercial Distribution

  • 10889981042677 ()

  • 4.0 Dia X 34mm
50-4034

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042660

Sierra Screw, 04.0 x 32mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4032
Not in Commercial Distribution

  • 10889981042660 ()

  • 4.0 Dia X 32mm
50-4032

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042653

Sierra Screw, 04.0 x 30mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4030
Not in Commercial Distribution

  • 10889981042653 ()

  • 4.0 Dia X 30mm
50-4030

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042646

Sierra Screw, 04.0 x 28mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4028
In Commercial Distribution

  • 10889981042646 ()

  • 4.0 Dia X 28mm
50-4028

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042639

Sierra Screw, 04.0 x 26mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4026
In Commercial Distribution

  • 10889981042639 ()

  • 4.0 Dia X 26mm
50-4026

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042622

Sierra Screw, 04.0 x 24mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4024
In Commercial Distribution

  • 10889981042622 ()

  • 4.0 Dia X 24mm
50-4024

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042615

Sierra Screw, 04.0 x 22mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4022
In Commercial Distribution

  • 10889981042615 ()

  • 4.0 Dia X 22mm
50-4022

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042608

Sierra Screw, 04.0 x 20mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4020
In Commercial Distribution

  • 10889981042608 ()

  • 4.0 Dia X 20mm
50-4020

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042592

Sierra Screw, 04.0 x 18mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4018
In Commercial Distribution

  • 10889981042592 ()

  • 4.0 Dia X 18mm
50-4018

  • Cannulated surgical drill bit, single-use
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