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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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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™ - 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™ - 10889981052157

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

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™ - 10889981052102

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

Vu CPOD™ - 10889981052089

Implant Tapered 12x14x10mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-2410
In Commercial Distribution

  • 10889981052089 ()

  • 12x14x10mm
11-11-2410

  • Vertebral body prosthesis, non-sterile

Vu CPOD™ - 10889981052065

Implant Tapered 12x14x8mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-2408
In Commercial Distribution

  • 10889981052065 ()

  • 12x14x8mm
11-11-2408

  • Vertebral body prosthesis, non-sterile

Vu CPOD™ - 10889981052041

Implant Tapered 12x14x6mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-2406
In Commercial Distribution

  • 10889981052041 ()

  • 12x14x6mm
11-11-2406

  • Vertebral body prosthesis, non-sterile

Vu CPOD™ - 10889981052027

Implant Tapered 10x12x10mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-0210
In Commercial Distribution

  • 10889981052027 ()

  • 10x12x10mm
11-11-0210

  • Vertebral body prosthesis, non-sterile
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