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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 - 10889981033736

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

Atoll - 10889981033712

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

Atoll - 10889981033699

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

Atoll - 10889981033675

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

Atoll - 10889981033668

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

Malibu™ - 10889981030834

PRECONTOURED ESS PLUS ROD, 5.5 x 600 mm
SEASPINE ORTHOPEDICS CORPORATION
15-3600
Not in Commercial Distribution

  • 10889981030834 ()

  • 5.5mm x 600 mm
15-3600

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

Malibu™ - 10889981030810

PRECONTOURED ESS PLUS ROD, 5.5 x 400 mm
SEASPINE ORTHOPEDICS CORPORATION
15-3400
In Commercial Distribution

  • 10889981030810 ()

  • 5.5mm x 400 mm
15-3400

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

NewPort™ - 10889981030773

Newport MIS Rod 2, 80mm
SEASPINE ORTHOPEDICS CORPORATION
60-0580
In Commercial Distribution

  • 10889981030773 ()

  • 80mm
60-0580

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

NewPort™ - 10889981030766

Newport MIS Rod 2, 75mm
SEASPINE ORTHOPEDICS CORPORATION
60-0575
In Commercial Distribution

  • 10889981030766 ()

  • 75mm
60-0575

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

NewPort™ - 10889981030742

Newport MIS Rod 2, 65mm
SEASPINE ORTHOPEDICS CORPORATION
60-0565
In Commercial Distribution

  • 10889981030742 ()

  • 65mm
60-0565

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