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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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Atoll - 10889981034047

4.0mm Occipital Screw, 13mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-31-4013
Not in Commercial Distribution

  • 10889981034047 ()

  • 4.0mm, 13mm
16-31-4013

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

Atoll - 10889981034016

4.0mm Occipital Screw, 10mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-31-4010
Not in Commercial Distribution

  • 10889981034016 ()

  • 4.0mm, 10mm
16-31-4010

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

Atoll - 10889981033996

4.0mm Occipital Screw, 8mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-31-4008
Not in Commercial Distribution

  • 10889981033996 ()

  • 4mm, 8mm
16-31-4008

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

Atoll - 10889981033972

4.0mm Occipital Screw, 6mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-31-4006
Not in Commercial Distribution

  • 10889981033972 ()

  • 4.0mm, 6mm
16-31-4006

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

Atoll - 10889981033958

Medium Occipital Plate (31-41mm). The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-30-3141
In Commercial Distribution

  • 10889981033958 ()

  • medium, 31-41mm
16-30-3141

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

Atoll - 10889981033941

Small Occipital Plate (25-35mm). The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-30-2535
In Commercial Distribution

  • 10889981033941 ()

  • small, 25-35mm
16-30-2535

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

Malibu™ - 10889981030827

PRECONTOURED ESS PLUS ROD, 5.5 x 500 mm
SEASPINE ORTHOPEDICS CORPORATION
15-3500
In Commercial Distribution

  • 10889981030827 ()

  • 5.5mm x 500 mm
15-3500

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

Malibu™ - 10889981030803

PRECONTOURED ESS PLUS ROD, 5.5 x 300 mm
SEASPINE ORTHOPEDICS CORPORATION
15-3300
In Commercial Distribution

  • 10889981030803 ()

  • 5.5mm x 300 mm
15-3300

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

Malibu™ - 10889981030797

ESS PLUS ROD, 5.5 x 450 mm
SEASPINE ORTHOPEDICS CORPORATION
15-2450
In Commercial Distribution

  • 10889981030797 ()

  • 5.5mm x 450 mm
15-2450

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

NewPort™ - 10889981030780

Newport MIS Rod 2, 90mm
SEASPINE ORTHOPEDICS CORPORATION
60-0590
In Commercial Distribution

  • 10889981030780 ()

  • 90mm
60-0590

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