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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™ - 10889981042554

Sierra Screw, 04.0 x 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
50-4010
In Commercial Distribution

  • 10889981042554 ()

  • 4.0 Dia X 10mm
50-4010

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042547

Sierra Screw, 04.0 x 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
50-4008
Not in Commercial Distribution

  • 10889981042547 ()

  • 4.0 Dia X 8mm
50-4008

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042530

Sierra Screw, 03.5 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
50-3540
Not in Commercial Distribution

  • 10889981042530 ()

  • 3.5 Dia X 40mm
50-3540

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042523

Sierra Screw, 03.5 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
50-3538
Not in Commercial Distribution

  • 10889981042523 ()

  • 3.5 Dia X 38mm
50-3538

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042516

Sierra Screw, 03.5 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
50-3536
Not in Commercial Distribution

  • 10889981042516 ()

  • 3.5 Dia X 36mm
50-3536

  • Cannulated surgical drill bit, single-use

Mariner MCT - 10889981170110

Cortical Screw Shank Driver, Long
Seaspine Orthopedics Corporation
MC2-003012
In Commercial Distribution

  • 10889981170110 ()
MC2-003012

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MCT - 10889981170103

Cortical Screw Shank Driver, Short
Seaspine Orthopedics Corporation
MC2-003011
In Commercial Distribution

  • 10889981170103 ()
MC2-003011

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MCT - 10889981170097

Cortical Screw Shank Driver
Seaspine Orthopedics Corporation
MC2-003010
In Commercial Distribution

  • 10889981170097 ()
MC2-003010

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner - 10889981182755

Reduction Screw Driver, Locking, Short
Seaspine Orthopedics Corporation
90-1243
In Commercial Distribution

  • 10889981182755 ()
90-1243

  • Surgical screwdriver, reusable

Mariner - 10889981182748

Reduction Screw Driver, Tri-Flat
Seaspine Orthopedics Corporation
90-1242
In Commercial Distribution

  • 10889981182748 ()
90-1242

  • Surgical screwdriver, reusable
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