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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 Screw,4.5 Dia x 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
50-4518
Not in Commercial Distribution

  • 10889981042769 ()

  • 4.5 Dia X 18mm
50-4518

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 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
50-4516
Not in Commercial Distribution

  • 10889981042752 ()

  • 4.5 Dia X 16mm
50-4516

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 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
50-4514
Not in Commercial Distribution

  • 10889981042745 ()

  • 4.5 Dia X 14mm
50-4514

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 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
50-4512
Not in Commercial Distribution

  • 10889981042738 ()

  • 4.5 Dia X 12mm
50-4512

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia 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
50-4510
In Commercial Distribution

  • 10889981042721 ()

  • 4.5 Dia X 10mm
50-4510

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia 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
50-4508
Not in Commercial Distribution

  • 10889981042714 ()

  • 4.5 Dia X 8mm
50-4508

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 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
50-4040
Not in Commercial Distribution

  • 10889981042707 ()

  • 4.0 Dia X 40mm
50-4040

  • Cannulated surgical drill bit, single-use
BULLET NOSE ROD, 5.5 x 150mm
SEASPINE ORTHOPEDICS CORPORATION
10-3150
In Commercial Distribution

  • 10889981062941 ()

  • 5.5 x 150mm
10-3150

  • Bone-screw internal spinal fixation system, non-sterile
CAP, 8MM
SEASPINE ORTHOPEDICS CORPORATION
10-0028
In Commercial Distribution

  • 10889981062699 ()

  • 8MM
10-0028

  • Bone-screw internal spinal fixation system, non-sterile
SETSCREW, 8MM
SEASPINE ORTHOPEDICS CORPORATION
10-0018
In Commercial Distribution

  • 10889981062675 ()

  • 8MM
10-0018

  • Bone-screw internal spinal fixation system, non-sterile
Pacifica Implant
SEASPINE ORTHOPEDICS CORPORATION
PACIMP
In Commercial Distribution

  • 10889981062651 ()
PACIMP

  • Vertebral body prosthesis, non-sterile
Laminoplasty Optional Implant Set
SEASPINE ORTHOPEDICS CORPORATION
LAMNOPT
In Commercial Distribution

  • 10889981062637 ()
LAMNOPT

  • Vertebral body prosthesis, non-sterile
Hollywood Nanometalene Implants
SEASPINE ORTHOPEDICS CORPORATION
HOLNMIMP
In Commercial Distribution

  • 10889981062613 ()
HOLNMIMP

  • Vertebral body prosthesis, non-sterile
Hollywood VI 30mm Implant Caddy Implants
SEASPINE ORTHOPEDICS CORPORATION
HOLVI30IMP
In Commercial Distribution

  • 10889981062590 ()

  • 30mm
HOLVI30IMP

  • Vertebral body prosthesis, non-sterile
Zuma-LP Caddy Implant
SEASPINE ORTHOPEDICS CORPORATION
ZUMLPIMP
In Commercial Distribution

  • 10889981062576 ()
ZUMLPIMP

  • Instrument tray, reusable
Zuma 38mm, 8 Deg Implants
SEASPINE ORTHOPEDICS CORPORATION
ZUM388IMP
In Commercial Distribution

  • 10889981062552 ()

  • 38mm, 8 Deg
ZUM388IMP

  • Instrument tray, reusable
Zuma 38mm, 12 Deg Implants
SEASPINE ORTHOPEDICS CORPORATION
ZUM3812IMP
In Commercial Distribution

  • 10889981062545 ()

  • 38mm, 12 Deg
ZUM3812IMP

  • Instrument tray, reusable
Zuma 26mm, 12 Deg Implants
SEASPINE ORTHOPEDICS CORPORATION
ZUM2612IMP
In Commercial Distribution

  • 10889981062538 ()

  • 26mm, 12 Deg
ZUM2612IMP

  • Instrument tray, reusable
Zuma-L 3 Implant
SEASPINE ORTHOPEDICS CORPORATION
ZUML3IMP
In Commercial Distribution

  • 10889981062521 ()
ZUML3IMP

  • Instrument tray, reusable
Zuma-L 2 Implant
SEASPINE ORTHOPEDICS CORPORATION
ZUML2IMP
In Commercial Distribution

  • 10889981062514 ()
ZUML2IMP

  • Instrument tray, reusable
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