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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 20mm 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
16-10-3520
In Commercial Distribution

  • 10889981052157 ()

  • 3.5mm x 20mm
16-10-3520

  • Bone-screw internal spinal fixation system, non-sterile
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
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
3.5mm x 14mm 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
16-10-3514
In Commercial Distribution

  • 10889981052126 ()

  • 3.5mm x 14mm
16-10-3514

  • Bone-screw internal spinal fixation system, non-sterile
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
3.5mm 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
16-10-3510
In Commercial Distribution

  • 10889981052102 ()

  • 3.5mm x10mm
16-10-3510

  • Bone-screw internal spinal fixation system, non-sterile
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
Implant Tapered 12x14x10mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-2410
In Commercial Distribution

  • 10889981052089 ()

  • 12x14x10mm
11-11-2410

  • Vertebral body prosthesis, non-sterile
Implant Tapered 12x14x9mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-2409
In Commercial Distribution

  • 10889981052072 ()

  • 12x14x9mm
11-11-2409

  • Vertebral body prosthesis, non-sterile
Implant Tapered 12x14x8mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-2408
In Commercial Distribution

  • 10889981052065 ()

  • 12x14x8mm
11-11-2408

  • Vertebral body prosthesis, non-sterile
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