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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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4.5mm x 12mm Poly Screw Assm. 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
16-12-4512
In Commercial Distribution

  • 10889981052942 ()

  • 4.5mm x 12mm
16-12-4512

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm x 10mm Poly Screw Assm. 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
16-12-4510
In Commercial Distribution

  • 10889981052935 ()

  • 4.5mm x 10mm
16-12-4510

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 16mm Poly Screw Assm. 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
16-12-3516
In Commercial Distribution

  • 10889981052355 ()

  • 3.5mm x 16mm
16-12-3516

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm 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
16-10-4028
In Commercial Distribution

  • 10889981052300 ()

  • 4.0mm x 28mm
16-10-4028

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm x 24mm 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
16-10-4024
In Commercial Distribution

  • 10889981052287 ()

  • 4.0mm x 24mm
16-10-4024

  • Bone-screw internal spinal fixation system, non-sterile
Implant Tapered 12x14x5mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-2405
In Commercial Distribution

  • 10889981052034 ()

  • 12x14x5mm
11-11-2405

  • Vertebral body prosthesis, non-sterile
Implant Tapered 10x12x10mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-0210
In Commercial Distribution

  • 10889981052027 ()

  • 10x12x10mm
11-11-0210

  • Vertebral body prosthesis, non-sterile
Implant Tapered 10x12x9mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-0209
In Commercial Distribution

  • 10889981052010 ()

  • 10x12x9mm
11-11-0209

  • Vertebral body prosthesis, non-sterile
Implant Tapered 10x12x8mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-0208
In Commercial Distribution

  • 10889981052003 ()

  • 10x12x8mm
11-11-0208

  • Vertebral body prosthesis, non-sterile
Implant Tapered 10x12x6mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-11-0206
In Commercial Distribution

  • 10889981051983 ()

  • 10x12x6mm
11-11-0206

  • Vertebral body prosthesis, non-sterile
Implant Non-Tapered 10x12x5mm (Strut)
SEASPINE ORTHOPEDICS CORPORATION
11-10-0205
Not in Commercial Distribution

  • 10889981051853 ()

  • 10x12x5mm
11-10-0205

  • Vertebral body prosthesis, non-sterile
Buttress Screw 6.5x20mm
SEASPINE ORTHOPEDICS CORPORATION
19-6520
In Commercial Distribution

  • 10889981051839 ()

  • 6.5x20mm
19-6520

  • Spinal fixation plate, non-bioabsorbable
Buttress Screw, 5.5x30mm
SEASPINE ORTHOPEDICS CORPORATION
19-5530
In Commercial Distribution

  • 10889981051815 ()

  • 5.5x30mm
19-5530

  • Spinal fixation plate, non-bioabsorbable
Buttress Screw, 5.5x20mm
SEASPINE ORTHOPEDICS CORPORATION
19-5520
Not in Commercial Distribution

  • 10889981051792 ()

  • 5.5x20mm
19-5520

  • Spinal fixation plate, non-bioabsorbable
Buttress Plate, 15x24mm
SEASPINE ORTHOPEDICS CORPORATION
19-1524
In Commercial Distribution

  • 10889981051785 ()

  • 15x24mm
19-1524

  • Spinal fixation plate, non-bioabsorbable
Buttress Plate, 15x19mm
SEASPINE ORTHOPEDICS CORPORATION
19-1519
In Commercial Distribution

  • 10889981051778 ()

  • 15x19mm
19-1519

  • Spinal fixation plate, non-bioabsorbable
Self-Drilling Variable Bone Screw, Single Lead 4.0 x 14mm
SEASPINE ORTHOPEDICS CORPORATION
21-8014
In Commercial Distribution

  • 10889981051761 ()

  • 4.5 x 18mm
21-8014

  • Spinal fixation plate, non-bioabsorbable
Self-Drilling Variable Bone Screw, Double Lead 4.5 x 20mm
SEASPINE ORTHOPEDICS CORPORATION
23-8520
In Commercial Distribution

  • 10889981051754 ()

  • 4.5 x 20mm
23-8520

  • Spinal fixation plate, non-bioabsorbable
Self-Drilling Variable Bone Screw, Double Lead 4.5 x 18mm
SEASPINE ORTHOPEDICS CORPORATION
23-8518
In Commercial Distribution

  • 10889981051747 ()

  • 4.5 x 18mm
23-8518

  • Spinal fixation plate, non-bioabsorbable
Self-Drilling Variable Bone Screw, Double Lead 4.5 x 16mm
SEASPINE ORTHOPEDICS CORPORATION
23-8516
In Commercial Distribution

  • 10889981051730 ()

  • 4.5 x 16mm
23-8516

  • Spinal fixation plate, non-bioabsorbable
Self-Drilling Variable Bone Screw, Double Lead 4.5 x 14mm
SEASPINE ORTHOPEDICS CORPORATION
23-8514
In Commercial Distribution

  • 10889981051723 ()

  • 4.5 x 14mm
23-8514

  • Spinal fixation plate, non-bioabsorbable
Self-Drilling Variable Bone Screw, Double Lead 4.5 x 12mm
SEASPINE ORTHOPEDICS CORPORATION
23-8512
In Commercial Distribution

  • 10889981051716 ()

  • 4.5 x 12mm
23-8512

  • Spinal fixation plate, non-bioabsorbable
Self-Drilling Variable Bone Screw, Double Lead 4.0 x 18mm
SEASPINE ORTHOPEDICS CORPORATION
23-8018
In Commercial Distribution

  • 10889981051686 ()

  • 4.0 x 18mm
23-8018

  • Spinal fixation plate, non-bioabsorbable
Self-Drilling Variable Bone Screw, Double Lead 4.0 x 16mm
SEASPINE ORTHOPEDICS CORPORATION
23-8016
In Commercial Distribution

  • 10889981051679 ()

  • 4.0 x 16mm
23-8016

  • Spinal fixation plate, non-bioabsorbable
Self-Drilling Variable Bone Screw, Double Lead 4.0 x 14mm
SEASPINE ORTHOPEDICS CORPORATION
23-8014
In Commercial Distribution

  • 10889981051662 ()

  • 4.0 x 14mm
23-8014

  • Spinal fixation plate, non-bioabsorbable
Self-Drilling Variable Bone Screw, Double Lead 4.0 x 12mm
SEASPINE ORTHOPEDICS CORPORATION
23-8012
In Commercial Distribution

  • 10889981051655 ()

  • 4.0 x 12mm
23-8012

  • Spinal fixation plate, non-bioabsorbable
Self-Drilling Variable Bone Screw, Double Lead 4.0 x 10mm
SEASPINE ORTHOPEDICS CORPORATION
23-8010
In Commercial Distribution

  • 10889981051648 ()

  • 4.0 x 10mm
23-8010

  • Spinal fixation plate, non-bioabsorbable
Bone Screw, Variable, Double Lead, 4.5 x 20mm
SEASPINE ORTHOPEDICS CORPORATION
23-4520
In Commercial Distribution

  • 10889981051631 ()

  • 4.5 x 20mm
23-4520

  • Spinal fixation plate, non-bioabsorbable
Bone Screw, Variable, Double Lead, 4.5 x 18mm
SEASPINE ORTHOPEDICS CORPORATION
23-4518
In Commercial Distribution

  • 10889981051624 ()

  • 4.5 x 18mm
23-4518

  • Spinal fixation plate, non-bioabsorbable
Bone Screw, Variable, Double Lead, 4.5 x 16mm
SEASPINE ORTHOPEDICS CORPORATION
23-4516
In Commercial Distribution

  • 10889981051617 ()

  • 4.5 x 16mm
23-4516

  • Spinal fixation plate, non-bioabsorbable
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