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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™ - 10889981052225

4.0mm x 12mm Standard Screw. 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
16-10-4012
In Commercial Distribution

  • 10889981052225 ()

  • 4.0mm x 12mm
16-10-4012

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

Atoll™ - 10889981052218

4.0mm x 10mm Standard Screw. 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
16-10-4010
Not in Commercial Distribution

  • 10889981052218 ()

  • 4.0mm x 10mm
16-10-4010

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

Atoll™ - 10889981052201

4.0mm x 8mm Standard Screw. 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
16-10-4008
In Commercial Distribution

  • 10889981052201 ()

  • 4.0mm x 8mm
16-10-4008

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

Atoll™ - 10889981052195

3.5mm x 28mm Standard Screw. 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
16-10-3528
In Commercial Distribution

  • 10889981052195 ()

  • 3.5mm x 28mm
16-10-3528

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

Atoll™ - 10889981052188

3.5mm x 26mm Standard Screw. 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
16-10-3526
Not in Commercial Distribution

  • 10889981052188 ()

  • 3.5mm x 26mm
16-10-3526

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

Atoll™ - 10889981052164

3.5mm x 22mm Standard Screw. 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
16-10-3522
In Commercial Distribution

  • 10889981052164 ()

  • 3.5mm x 22mm
16-10-3522

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

Atoll™ - 10889981052140

3.5mm x 18mm Standard Screw. 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
16-10-3518
Not in Commercial Distribution

  • 10889981052140 ()

  • 3.5mm x 18mm
16-10-3518

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

Atoll™ - 10889981052133

3.5mm x 16mm Standard Screw. 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
16-10-3516
In Commercial Distribution

  • 10889981052133 ()

  • 3.5mm x 16mm
16-10-3516

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

Atoll™ - 10889981052119

3.5mm x 12mm Standard Screw. 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
16-10-3512
In Commercial Distribution

  • 10889981052119 ()

  • 3.5mm x 12mm
16-10-3512

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

Atoll™ - 10889981052096

3.5mm x 8mm Standard Screw. 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
16-10-3508
In Commercial Distribution

  • 10889981052096 ()

  • 3.5mm x 8mm
16-10-3508

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