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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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Zuma-C Implant, 13x12x7mm
Seaspine Orthopedics Corporation
57-2307
In Commercial Distribution

  • 10889981053093 ()

  • 13x12x7mm
57-2307

  • Vertebral body prosthesis, non-sterile
4.5mm x 28mm 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
16-12-4528
In Commercial Distribution

  • 10889981053024 ()

  • 4.5mm x 28mm
16-12-4528

  • Spinal bone screw, non-bioabsorbable
3.5mm x 20mm Smooth Shaft 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
16-13-3520
In Commercial Distribution

  • 10889981052652 ()

  • 3.5mm x 20mm
16-13-3520

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm x 8mm 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
16-12-4508
In Commercial Distribution

  • 10889981052638 ()

  • 4.5mm x 8mm
16-12-4508

  • Spinal bone screw, non-bioabsorbable
4.0mm x 50mm 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
16-12-4050
In Commercial Distribution

  • 10889981052621 ()

  • 4.0mm x 50mm
16-12-4050

  • Spinal bone screw, non-bioabsorbable
4.0mm x 45mm 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
16-12-4045
In Commercial Distribution

  • 10889981052614 ()

  • 4.0mm x 45mm
16-12-4045

  • Spinal bone screw, non-bioabsorbable
4.0mm x 35mm 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
16-12-4035
In Commercial Distribution

  • 10889981052591 ()

  • 4.0mm x 35mm
16-12-4035

  • Spinal bone screw, non-bioabsorbable
4.0mm x 28mm 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
16-12-4028
In Commercial Distribution

  • 10889981052577 ()

  • 4.0mm x 28mm
16-12-4028

  • Spinal bone screw, non-bioabsorbable
4.0mm x 26mm 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
16-12-4026
In Commercial Distribution

  • 10889981052560 ()

  • 4.0mm x 26mm
16-12-4026

  • Spinal bone screw, non-bioabsorbable
4.0mm x 24mm 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
16-12-4024
In Commercial Distribution

  • 10889981052553 ()

  • 4.0mm x 24mm
16-12-4024

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