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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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Newport - 10381780030508

NewPort MIS Screw, DIA 5.5 x 40mm
Seaspine, Inc.
60-5540
Not in Commercial Distribution

  • M5566055401 ()
  • 10381780030508 ()

  • DIA 5.5 x 40mm
60-5540

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

Newport - 10381780030492

NewPort MIS Screw, DIA 5.5 x 35mm
Seaspine, Inc.
60-5535
Not in Commercial Distribution

  • M5566055351 ()
  • 10381780030492 ()

  • DIA 5.5 x 35mm
60-5535

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

Newport - 10381780030485

NewPort MIS Screw, DIA 5.5 x 30mm
Seaspine, Inc.
60-5530
Not in Commercial Distribution

  • M5566055301 ()
  • 10381780030485 ()

  • DIA 5.5 x 30mm
60-5530

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

Newport - 10381780030478

NewPort MIS Screw, DIA 5.5 x 25mm
Seaspine, Inc.
60-5525
Not in Commercial Distribution

  • M5566055251 ()
  • 10381780030478 ()

  • DIA 5.5 x 25mm
60-5525

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

Atoll™ - 10889981053079

4.5mm 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
16-12-4550
In Commercial Distribution

  • 10889981053079 ()

  • 4.5mm x 50mm
16-12-4550

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

Atoll™ - 10889981053062

4.5mm 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
16-12-4545
In Commercial Distribution

  • 10889981053062 ()

  • 4.5mm x 45mm
16-12-4545

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

Atoll™ - 10889981053055

4.5mm x 40mm 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
16-12-4540
In Commercial Distribution

  • 10889981053055 ()

  • 4.5mm x 40mm
16-12-4540

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

Atoll™ - 10889981053048

4.5mm 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
16-12-4535
In Commercial Distribution

  • 10889981053048 ()

  • 4.5mm x 35mm
16-12-4535

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

Atoll™ - 10889981053031

4.5mm x 30mm 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
16-12-4530
In Commercial Distribution

  • 10889981053031 ()

  • 4.5mm x 30mm
16-12-4530

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

Atoll™ - 10889981053024

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

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