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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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Sierra™ - 10889910059165

S2S CrossBar, 33 - 47mm. 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
50-2023
Not in Commercial Distribution

  • 10889910059165 ()

  • 33 - 47mm
50-2023

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059158

S2S CrossBar, 27 - 35mm. 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
50-2022
Not in Commercial Distribution

  • 10889910059158 ()

  • 27 - 35mm
50-2022

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059141

S2S CrossBar, 24 - 29mm. 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
50-2021
Not in Commercial Distribution

  • 10889910059141 ()

  • 24 - 29mm
50-2021

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059134

Sierra Set Screw. 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
50-1005
Not in Commercial Distribution

  • 10889910059134 ()
50-1005

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059127

Axial Rod Connector, 3.5/6.35. 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
50-0935
Not in Commercial Distribution

  • 10889910059127 ()

  • 3.5/6.35
50-0935

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059110

Axial Rod Connector, 3.5/5.5. 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
50-0835
Not in Commercial Distribution

  • 10889910059110 ()

  • 3.5/5.5
50-0835

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059097

Parallel Rod Connector, 3.5/6.35, Single. 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
50-0635
Not in Commercial Distribution

  • 10889910059097 ()

  • 3.5/6.35
50-0635

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059073

Parallel Rod Connector, 3.5/3.5, Single. 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
50-0435
Not in Commercial Distribution

  • 10889910059073 ()

  • 3.5/3.5
50-0435

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059059

Parallel Rod Connector, 3.5/5.5, Double. 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
50-0235
Not in Commercial Distribution

  • 10889910059059 ()

  • 3.5/5.5
50-0235

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059035

Connector Set Screw. 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
50-0015
Not in Commercial Distribution

  • 10889910059035 ()
50-0015

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059103

Axial Rod Connector, 3.5/3.5. 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
50-0735
Not in Commercial Distribution

  • 10889910059103 ()

  • 3.5/3.5
50-0735

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059080

Parallel Rod Connector, 3.5/5.5, Single. 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
50-0535
Not in Commercial Distribution

  • 10889910059080 ()

  • 3.5/5.5
50-0535

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059066

Parallel Rod Connector, 3.5/6.35, Double. 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
50-0335
Not in Commercial Distribution

  • 10889910059066 ()

  • 3.5/6.35
50-0335

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889910059042

Parallel Rod Connector, 3.5/3.5, Double. 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
50-0135
Not in Commercial Distribution

  • 10889910059042 ()

  • 3.5/3.5
50-0135

  • Vertebral body prosthesis, non-sterile

NorthStar - 10889981320904

Fav Angle Ext Tab Screw, 5.5mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315550
In Commercial Distribution

  • 10889981320904 ()
PC1-315550

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

NorthStar - 10889981320898

Fav Angle Ext Tab Screw, 5.5mm x 48mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315548
In Commercial Distribution

  • 10889981320898 ()
PC1-315548

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

NorthStar - 10889981320881

Fav Angle Ext Tab Screw, 5.5mm x 46mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315546
In Commercial Distribution

  • 10889981320881 ()
PC1-315546

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

NorthStar - 10889981320874

Fav Angle Ext Tab Screw, 5.5mm x 44mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315544
In Commercial Distribution

  • 10889981320874 ()
PC1-315544

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

NorthStar - 10889981320867

Fav Angle Ext Tab Screw, 5.5mm x 42mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315542
In Commercial Distribution

  • 10889981320867 ()
PC1-315542

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

NorthStar - 10889981320850

Fav Angle Ext Tab Screw, 5.5mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315540
In Commercial Distribution

  • 10889981320850 ()
PC1-315540

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

NorthStar - 10889981320843

Fav Angle Ext Tab Screw, 5.5mm x 38mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315538
In Commercial Distribution

  • 10889981320843 ()
PC1-315538

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

NorthStar - 10889981320836

Fav Angle Ext Tab Screw, 5.5mm x 36mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315536
In Commercial Distribution

  • 10889981320836 ()
PC1-315536

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

NorthStar - 10889981320829

Fav Angle Ext Tab Screw, 5.5mm x 34mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315534
In Commercial Distribution

  • 10889981320829 ()
PC1-315534

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

NorthStar - 10889981320812

Fav Angle Ext Tab Screw, 5.5mm x 32mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315532
In Commercial Distribution

  • 10889981320812 ()
PC1-315532

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

NorthStar - 10889981320805

Fav Angle Ext Tab Screw, 5.5mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315530
In Commercial Distribution

  • 10889981320805 ()
PC1-315530

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

NorthStar - 10889981320799

Fav Angle Ext Tab Screw, 5.5mm x 28mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315528
In Commercial Distribution

  • 10889981320799 ()
PC1-315528

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

NorthStar - 10889981320782

Fav Angle Ext Tab Screw, 5.5mm x 26mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315526
In Commercial Distribution

  • 10889981320782 ()
PC1-315526

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

NorthStar - 10889981320775

Fav Angle Ext Tab Screw, 5.5mm x 24mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315524
In Commercial Distribution

  • 10889981320775 ()
PC1-315524

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

NorthStar - 10889981320768

Fav Angle Ext Tab Screw, 5.5mm x 22mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-315522
In Commercial Distribution

  • 10889981320768 ()
PC1-315522

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

NorthStar - 10889981320485

Ext Tab Smooth Shank Screw, 4.0mm x 46mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314046
In Commercial Distribution

  • 10889981320485 ()
PC1-314046

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

NorthStar - 10889981320478

Ext Tab Smooth Shank Screw, 4.0mm x 44mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314044
In Commercial Distribution

  • 10889981320478 ()
PC1-314044

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

NorthStar - 10889981320461

Ext Tab Smooth Shank Screw, 4.0mm x 42mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314042
In Commercial Distribution

  • 10889981320461 ()
PC1-314042

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

NorthStar - 10889981320454

Ext Tab Smooth Shank Screw, 4.0mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314040
In Commercial Distribution

  • 10889981320454 ()
PC1-314040

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

NorthStar - 10889981320447

Ext Tab Smooth Shank Screw, 4.0mm x 38mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314038
In Commercial Distribution

  • 10889981320447 ()
PC1-314038

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

NorthStar - 10889981320430

Ext Tab Smooth Shank Screw, 4.0mm x 36mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314036
In Commercial Distribution

  • 10889981320430 ()
PC1-314036

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

NorthStar - 10889981320423

Ext Tab Smooth Shank Screw, 4.0mm x 34mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314034
In Commercial Distribution

  • 10889981320423 ()
PC1-314034

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

NorthStar - 10889981320416

Ext Tab Smooth Shank Screw, 4.0mm x 32mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314032
In Commercial Distribution

  • 10889981320416 ()
PC1-314032

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

NorthStar - 10889981320409

Ext Tab Smooth Shank Screw, 4.0mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314030
In Commercial Distribution

  • 10889981320409 ()
PC1-314030

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

NorthStar - 10889981320393

Ext Tab Smooth Shank Screw, 4.0mm x 28mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314028
In Commercial Distribution

  • 10889981320393 ()
PC1-314028

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

NorthStar - 10889981320386

Ext Tab Smooth Shank Screw, 4.0mm x 26mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314026
In Commercial Distribution

  • 10889981320386 ()
PC1-314026

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

NorthStar - 10889981320379

Ext Tab Smooth Shank Screw, 4.0mm x 24mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314024
In Commercial Distribution

  • 10889981320379 ()
PC1-314024

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

NorthStar - 10889981320362

Ext Tab Smooth Shank Screw, 4.0mm x 22mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314022
In Commercial Distribution

  • 10889981320362 ()
PC1-314022

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

NorthStar - 10889981320355

Ext Tab Smooth Shank Screw, 4.0mm x 20mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-314020
In Commercial Distribution

  • 10889981320355 ()
PC1-314020

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

NorthStar - 10889981320300

Ext Tab Smooth Shank Screw, 3.5mm x 42mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-313542
In Commercial Distribution

  • 10889981320300 ()
PC1-313542

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

NorthStar - 10889981320287

Ext Tab Smooth Shank Screw, 3.5mm x 38mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-313538
In Commercial Distribution

  • 10889981320287 ()
PC1-313538

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

NorthStar - 10889981320270

Ext Tab Smooth Shank Screw, 3.5mm x 36mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-313536
In Commercial Distribution

  • 10889981320270 ()
PC1-313536

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

NorthStar - 10889981320263

Ext Tab Smooth Shank Screw, 3.5mm x 34mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-313534
In Commercial Distribution

  • 10889981320263 ()
PC1-313534

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

NorthStar - 10889981320249

Ext Tab Smooth Shank Screw, 3.5mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-313530
In Commercial Distribution

  • 10889981320249 ()
PC1-313530

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

NorthStar - 10889981320232

Ext Tab Smooth Shank Screw, 3.5mm x 28mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-313528
In Commercial Distribution

  • 10889981320232 ()
PC1-313528

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

NorthStar - 10889981320218

Ext Tab Smooth Shank Screw, 3.5mm x 24mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-313524
In Commercial Distribution

  • 10889981320218 ()
PC1-313524

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