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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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Polyaxial Screw, 8.50mm x 80mm
SEASPINE ORTHOPEDICS CORPORATION
25-12-8580
Not in Commercial Distribution

  • 10889981022952 ()

  • 8.50mm x 80mm
25-12-8580

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 8.50mm x 75mm
SEASPINE ORTHOPEDICS CORPORATION
25-12-8575
Not in Commercial Distribution

  • 10889981022945 ()

  • 8.50mm x 75mm
25-12-8575

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 8.50mm x 70mm
SEASPINE ORTHOPEDICS CORPORATION
25-12-8570
Not in Commercial Distribution

  • 10889981022938 ()

  • 8.50mm x 70mm
25-12-8570

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 8.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
25-12-8565
Not in Commercial Distribution

  • 10889981022921 ()

  • 8.50mm x 65mm
25-12-8565

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 8.50mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
25-12-8560
In Commercial Distribution

  • 10889981022914 ()

  • 8.50mm x 60mm
25-12-8560

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 8.50mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
25-12-8550
In Commercial Distribution

  • 10889981022891 ()

  • 8.50mm x 50mm
25-12-8550

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 8.50mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
25-12-8535
In Commercial Distribution

  • 10889981022860 ()

  • 8.50mm x 35mm
25-12-8535

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw, 8.50mm x 20mm
SEASPINE ORTHOPEDICS CORPORATION
25-12-8520
Not in Commercial Distribution

  • 10889981022839 ()

  • 8.50mm x 20mm
25-12-8520

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 80mm Rod. 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
16-18-0080
In Commercial Distribution

  • 10889981033798 ()

  • 3.5mm x 80mm
16-18-0080

  • Bone-screw internal spinal fixation system, non-sterile
Open Lateral Offset. 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
16-24-0020
In Commercial Distribution

  • 10889981033781 ()
16-24-0020

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