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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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3.5mm x 120mm Rod. 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
16-18-0120
In Commercial Distribution

  • 10889981033804 ()

  • 3.5mm x 120mm
16-18-0120

  • Bone-screw internal spinal fixation system, non-sterile
Closed Lateral Offset Asm. 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
16-24-0011
Not in Commercial Distribution

  • 10889981033774 ()
16-24-0011

  • Bone-screw internal spinal fixation system, non-sterile
Slimline 3.5mm to 5.5mm Connector Asm. 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
16-23-5540
In Commercial Distribution

  • 10889981033750 ()

  • 3.5mm to 5.5mm
16-23-5540

  • Bone-screw internal spinal fixation system, non-sterile
Inline 3.5mm to 5.5mm Connector Asm. 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
16-23-5520
In Commercial Distribution

  • 10889981033736 ()

  • 3.5mm to 5.5mm
16-23-5520

  • Bone-screw internal spinal fixation system, non-sterile
Offset 5.5mm to 3.5mm Connector Asm. 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
16-23-5510
In Commercial Distribution

  • 10889981033729 ()

  • 5.5mm to 3.5mm
16-23-5510

  • Bone-screw internal spinal fixation system, non-sterile
Clamshell 3.5mm to 3.5mm Connector Asm. 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
16-23-3530
Not in Commercial Distribution

  • 10889981033712 ()

  • 3.5mm to 3.5mm
16-23-3530

  • Bone-screw internal spinal fixation system, non-sterile
Offset 3.5mm to 3.5mm Connector Asm. 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
16-23-3510
In Commercial Distribution

  • 10889981033699 ()

  • 3.5mm to 3.5mm
16-23-3510

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm to 5.5mm Transition Rod - 600mm. 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
16-18-0001
In Commercial Distribution

  • 10889981033675 ()

  • 3.5mm to 5.5mm, 600mm
16-18-0001

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm to 5.5mm Transition Rod - 385mm. 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
16-18-0000
In Commercial Distribution

  • 10889981033668 ()

  • 3.5mm to 5.5mm, 385mm
16-18-0000

  • Bone-screw internal spinal fixation system, non-sterile
Pacifica Implant 9mm x 24mm x 14mm
SEASPINE ORTHOPEDICS CORPORATION
33-2614
In Commercial Distribution

  • 10889981031619 ()
33-2614

  • Vertebral body prosthesis
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