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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™ - 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™ - 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™ - 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™ - 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™ - 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™ - 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™ - 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

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™ - 10889981044022

Sierra Extended Tab Screw, 04.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
51-4550
Not in Commercial Distribution

  • 10889981044022 ()

  • 4.5 Dia X 50mm
51-4550

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981044015

Sierra Extended Tab Screw, 04.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
51-4545
Not in Commercial Distribution

  • 10889981044015 ()

  • 4.5 Dia X 45mm
51-4545

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981044008

Sierra Extended Tab Screw, 04.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
51-4540
Not in Commercial Distribution

  • 10889981044008 ()

  • 4.5 Dia X 40mm
51-4540

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043995

Sierra Extended Tab Screw, 04.5 x 38mm
SEASPINE ORTHOPEDICS CORPORATION
51-4538
Not in Commercial Distribution

  • 10889981043995 ()

  • 4.5 Dia X 38mm
51-4538

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043988

Sierra Extended Tab Screw, 04.5 x 36mm
SEASPINE ORTHOPEDICS CORPORATION
51-4536
Not in Commercial Distribution

  • 10889981043988 ()

  • 4.5 Dia X 36mm
51-4536

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043971

Sierra Extended Tab Screw, 04.5 x 34mm
SEASPINE ORTHOPEDICS CORPORATION
51-4534
Not in Commercial Distribution

  • 10889981043971 ()

  • 4.5 Dia X 34mm
51-4534

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043964

Sierra Extended Tab Screw, 04.5 x 32mm
SEASPINE ORTHOPEDICS CORPORATION
51-4532
Not in Commercial Distribution

  • 10889981043964 ()

  • 4.5 Dia X 32mm
51-4532

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043957

Sierra Extended Tab Screw, 04.5 x 30mm
SEASPINE ORTHOPEDICS CORPORATION
51-4530
Not in Commercial Distribution

  • 10889981043957 ()

  • 4.5 Dia X 30mm
51-4530

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043940

Sierra Extended Tab Screw, 04.5 x 28mm
SEASPINE ORTHOPEDICS CORPORATION
51-4528
In Commercial Distribution

  • 10889981043940 ()

  • 4.5 Dia X 28mm
51-4528

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043933

Sierra Extended Tab Screw, 04.5 x 26mm
SEASPINE ORTHOPEDICS CORPORATION
51-4526
In Commercial Distribution

  • 10889981043933 ()

  • 4.5 Dia X 26mm
51-4526

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043926

Sierra Extended Tab Screw, 04.5 x 24mm
SEASPINE ORTHOPEDICS CORPORATION
51-4524
In Commercial Distribution

  • 10889981043926 ()

  • 4.5 Dia X 24mm
51-4524

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043919

Sierra Extended Tab Screw, 04.5 x 22mm
SEASPINE ORTHOPEDICS CORPORATION
51-4522
In Commercial Distribution

  • 10889981043919 ()

  • 4.5 Dia X 22mm
51-4522

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043902

Sierra Extended Tab Screw, 04.5 x 20mm
SEASPINE ORTHOPEDICS CORPORATION
51-4520
In Commercial Distribution

  • 10889981043902 ()

  • 4.5 Dia X 20mm
51-4520

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043896

Sierra Extended Tab Screw, 04.5 x 18mm
SEASPINE ORTHOPEDICS CORPORATION
51-4518
In Commercial Distribution

  • 10889981043896 ()

  • 4.5 Dia X 18mm
51-4518

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043889

Sierra Extended Tab Screw, 04.5 x 16mm
SEASPINE ORTHOPEDICS CORPORATION
51-4516
In Commercial Distribution

  • 10889981043889 ()

  • 4.5 Dia X 16mm
51-4516

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043872

Sierra Extended Tab Screw, 04.5 x 14mm
SEASPINE ORTHOPEDICS CORPORATION
51-4514
In Commercial Distribution

  • 10889981043872 ()

  • 4.5 Dia X 14mm
51-4514

  • Cannulated surgical drill bit, single-use
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