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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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Sierra™ - 10889981043162

Rod, 3.5 x 50mm. 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
50-6150
In Commercial Distribution

  • 10889981043162 ()

  • 3.5 X 50mm
50-6150

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043155

Rod, 3.5 x 40mm. 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
50-6140
In Commercial Distribution

  • 10889981043155 ()

  • 3.5 X 40mm
50-6140

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043148

Rod, 3.5 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
50-6130
In Commercial Distribution

  • 10889981043148 ()

  • 3.5 X 30mm
50-6130

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043131

Rod, 3.5 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
50-6120
In Commercial Distribution

  • 10889981043131 ()

  • 3.5 X 20mm
50-6120

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043124

Rod, 3.5 x 300mm. 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
50-6090
In Commercial Distribution

  • 10889981043124 ()

  • 3.5 X 300mm
50-6090

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043117

Rod, 3.5 x 80mm. 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
50-6080
In Commercial Distribution

  • 10889981043117 ()

  • 3.5 X 80mm
50-6080

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043100

Rod, 3.5 x 70mm. 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
50-6070
Not in Commercial Distribution

  • 10889981043100 ()

  • 3.5 X 70mm
50-6070

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043094

Rod, 3.5 x 60mm. 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
50-6060
In Commercial Distribution

  • 10889981043094 ()

  • 3.5 X 60mm
50-6060

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043087

Rod, 3.5 x 50mm. 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
50-6050
In Commercial Distribution

  • 10889981043087 ()

  • 3.5 X 50mm
50-6050

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043070

Rod, 3.5 x 40mm. 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
50-6040
Not in Commercial Distribution

  • 10889981043070 ()

  • 3.5 X 40mm
50-6040

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043063

Rod, 3.5 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
50-6030
Not in Commercial Distribution

  • 10889981043063 ()

  • 3.5 X 30mm
50-6030

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043056

Rod, 3.5 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
50-6020
Not in Commercial Distribution

  • 10889981043056 ()

  • 3.5 X 20mm
50-6020

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043049

Occipital Screw, 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
50-5020
Not in Commercial Distribution

  • 10889981043049 ()

  • 20mm
50-5020

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043032

Occipital Screw, 19mm. 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
50-5019
Not in Commercial Distribution

  • 10889981043032 ()

  • 19mm
50-5019

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043025

Occipital Screw, 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
50-5018
Not in Commercial Distribution

  • 10889981043025 ()

  • 18mm
50-5018

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043001

Occipital Screw, 16mm. 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
50-5016
Not in Commercial Distribution

  • 10889981043001 ()

  • 16mm
50-5016

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042998

Occipital Screw, 15mm. 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
50-5015
Not in Commercial Distribution

  • 10889981042998 ()

  • 15mm
50-5015

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042981

Occipital Screw, 14mm. 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
50-5014
In Commercial Distribution

  • 10889981042981 ()

  • 14mm
50-5014

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042974

Occipital Screw, 13mm. 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
50-5013
In Commercial Distribution

  • 10889981042974 ()

  • 13mm
50-5013

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042967

Occipital Screw, 12mm. 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
50-5012
In Commercial Distribution

  • 10889981042967 ()

  • 12mm
50-5012

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042950

Occipital Screw, 11mm. 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
50-5011
In Commercial Distribution

  • 10889981042950 ()

  • 11mm
50-5011

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042943

Occipital Screw, 10mm. 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
50-5010
In Commercial Distribution

  • 10889981042943 ()

  • 10mm
50-5010

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042936

Occipital Screw, 9mm. 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
50-5009
In Commercial Distribution

  • 10889981042936 ()

  • 9mm
50-5009

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042929

Occipital Screw, 8mm. 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
50-5008
In Commercial Distribution

  • 10889981042929 ()

  • 8mm
50-5008

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042912

Occipital Screw, 7mm. 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
50-5007
In Commercial Distribution

  • 10889981042912 ()

  • 7mm
50-5007

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042905

Occipital Screw, 6mm. 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
50-5006
In Commercial Distribution

  • 10889981042905 ()

  • 6mm
50-5006

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042899

Sierra Screw,4.5 Dia x 50mm. 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
50-4550
Not in Commercial Distribution

  • 10889981042899 ()

  • 4.5 Dia X 50mm
50-4550

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042882

Sierra Screw,4.5 Dia x 45mm. 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
50-4545
Not in Commercial Distribution

  • 10889981042882 ()

  • 4.5 Dia X 45mm
50-4545

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042875

Sierra Screw,4.5 Dia x 40mm. 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
50-4540
Not in Commercial Distribution

  • 10889981042875 ()

  • 4.5 Dia X 40mm
50-4540

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042868

Sierra Screw,4.5 Dia 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
50-4538
Not in Commercial Distribution

  • 10889981042868 ()

  • 4.5 Dia X 38mm
50-4538

  • Cannulated surgical drill bit, single-use
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