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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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3.5mm x 14mm 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
16-10-3514
In Commercial Distribution

  • 10889981052126 ()

  • 3.5mm x 14mm
16-10-3514

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 12mm 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
16-10-3512
In Commercial Distribution

  • 10889981052119 ()

  • 3.5mm x 12mm
16-10-3512

  • Bone-screw internal spinal fixation system, non-sterile
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
3.5mm x 8mm 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
16-10-3508
In Commercial Distribution

  • 10889981052096 ()

  • 3.5mm x 8mm
16-10-3508

  • Bone-screw internal spinal fixation system, non-sterile
39x30mm Trial Rasp 16mm 15 deg
SEASPINE ORTHOPEDICS CORPORATION
21-25-3916
In Commercial Distribution

  • 10889981042240 ()

  • 39x30mm, 16mm 15 deg
21-25-3916

  • Bone-screw internal spinal fixation system, non-sterile
39x30mm Trial Rasp 14mm 15 deg
SEASPINE ORTHOPEDICS CORPORATION
21-25-3914
In Commercial Distribution

  • 10889981042233 ()

  • 39x30mm, 14mm 15 deg
21-25-3914

  • Bone-screw internal spinal fixation system, non-sterile
39x30mm Trial Rasp 12mm 15 deg
SEASPINE ORTHOPEDICS CORPORATION
21-25-3912
In Commercial Distribution

  • 10889981042226 ()

  • 39x30mm, 12mm 15 deg
21-25-3912

  • Bone-screw internal spinal fixation system, non-sterile
35x27mm Trial Rasp 16mm 15 deg
SEASPINE ORTHOPEDICS CORPORATION
21-25-3516
In Commercial Distribution

  • 10889981042219 ()

  • 35x27mm, 16mm 15 deg
21-25-3516

  • Bone-screw internal spinal fixation system, non-sterile
35x27mm Trial Rasp 14mm 15 deg
SEASPINE ORTHOPEDICS CORPORATION
21-25-3514
In Commercial Distribution

  • 10889981042202 ()

  • 35x27mm, 14mm 15 deg
21-25-3514

  • Bone-screw internal spinal fixation system, non-sterile
35x27mm Trial Rasp 12mm 15 deg
SEASPINE ORTHOPEDICS CORPORATION
21-25-3512
In Commercial Distribution

  • 10889981042196 ()

  • 35x27mm, 12mm 15 deg
21-25-3512

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