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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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Zuma-C Trial, 17x12.5x8mm w/Stop
SEASPINE ORTHOPEDICS CORPORATION
95-7618
In Commercial Distribution

  • 10889981053925 ()

  • 17x12.5x8mm
95-7618

  • Spinal implant trial
Zuma-C Trial, 17x12.5x6mm w/Stop
SEASPINE ORTHOPEDICS CORPORATION
95-7616
In Commercial Distribution

  • 10889981053901 ()

  • 17x12.5x6mm
95-7616

  • Spinal implant trial
Zuma-C Trial, 17x13.5x11mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
95-7611
In Commercial Distribution

  • 10889981053888 ()

  • 17x13.5x11mm
95-7611

  • Spinal implant trial
Pre-Bent Occipital Rod (110 degrees -240mm). 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
16-33-0240
In Commercial Distribution

  • 10889981034511 ()

  • 110 degrees - 240mm
16-33-0240

  • Bone-screw internal spinal fixation system, non-sterile
Pre-Bent Occipital Rod (110 degrees -205mm). 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
16-33-0205
In Commercial Distribution

  • 10889981034504 ()

  • 110 degrees - 205mm
16-33-0205

  • Bone-screw internal spinal fixation system, non-sterile
Pre-Bent Occipital Rod (110 degrees -170mm). 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
16-33-0170
In Commercial Distribution

  • 10889981034498 ()

  • 110 degrees - 170mm
16-33-0170

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 18mm. 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
16-32-4518
In Commercial Distribution

  • 10889981034481 ()

  • 4.5mm, 18mm
16-32-4518

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 17mm. 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
16-32-4517
In Commercial Distribution

  • 10889981034474 ()

  • 4.5mm, 17mm
16-32-4517

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 16mm. 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
16-32-4516
In Commercial Distribution

  • 10889981034467 ()

  • 4.5mm, 16mm
16-32-4516

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 15mm. 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
16-32-4515
In Commercial Distribution

  • 10889981034450 ()

  • 4.5mm, 15mm
16-32-4515

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