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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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Newport - 10381780030515

NewPort MIS Screw, DIA 5.5 x 45mm
Seaspine, Inc.
60-5545
Not in Commercial Distribution

  • M5566055451 ()
  • 10381780030515 ()

  • DIA 5.5 x 45mm
60-5545

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

Newport - 10381780030508

NewPort MIS Screw, DIA 5.5 x 40mm
Seaspine, Inc.
60-5540
Not in Commercial Distribution

  • M5566055401 ()
  • 10381780030508 ()

  • DIA 5.5 x 40mm
60-5540

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

Newport - 10381780030485

NewPort MIS Screw, DIA 5.5 x 30mm
Seaspine, Inc.
60-5530
Not in Commercial Distribution

  • M5566055301 ()
  • 10381780030485 ()

  • DIA 5.5 x 30mm
60-5530

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

Newport - 10381780030478

NewPort MIS Screw, DIA 5.5 x 25mm
Seaspine, Inc.
60-5525
Not in Commercial Distribution

  • M5566055251 ()
  • 10381780030478 ()

  • DIA 5.5 x 25mm
60-5525

  • 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
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