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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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Malibu - 10889981079291

COBALT LOCKING CAP
SEASPINE ORTHOPEDICS CORPORATION
76-0010
In Commercial Distribution

  • 10889981079291 ()
76-0010

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

UCR - 10889981036201

PEDICLE 9.0 X 5.0 MM
SEASPINE ORTHOPEDICS CORPORATION
14-9050
In Commercial Distribution

  • 10889981036201 ()

  • 9.0 X 5.0 MM
14-9050

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

UCR - 10889981036195

LAMINAR 7.0 X 8.0 MM
SEASPINE ORTHOPEDICS CORPORATION
14-7080
In Commercial Distribution

  • 10889981036195 ()

  • 7.0 X 8.0 MM
14-7080

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

UCR - 10889981036188

LAMINAR 7.0 X 6.5 MM
SEASPINE ORTHOPEDICS CORPORATION
14-7065
In Commercial Distribution

  • 10889981036188 ()

  • 7.0 X 6.5 MM
14-7065

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

Atoll - 10889981034511

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

Atoll - 10889981034504

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

Atoll - 10889981034474

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

Atoll - 10889981034467

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

Atoll - 10889981034450

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

Atoll - 10889981034443

4.5mm Self Tapping Occipital Screw, 14mm. 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
16-32-4514
In Commercial Distribution

  • 10889981034443 ()

  • 4.5mm, 14mm
16-32-4514

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