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 4.75 X 50mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4750
In Commercial Distribution

  • 10889981138813 ()

  • 4.75 X 50mm
61-4750

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 45mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4745
In Commercial Distribution

  • 10889981138806 ()

  • 4.75 X 45mm
61-4745

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 40mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4740
In Commercial Distribution

  • 10889981138790 ()

  • 4.75 X 40mm
61-4740

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 35mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4735
In Commercial Distribution

  • 10889981138783 ()

  • 4.75 X 35mm
61-4735

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 30mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4730
In Commercial Distribution

  • 10889981138776 ()

  • 4.75 X 30mm
61-4730

  • Bone-screw internal spinal fixation system, non-sterile
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
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
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
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
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
4.5mm Self Tapping Occipital Screw, 13mm. 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
16-32-4513
In Commercial Distribution

  • 10889981034436 ()

  • 4.5mm, 13mm
16-32-4513

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 12mm. 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
16-32-4512
In Commercial Distribution

  • 10889981034429 ()

  • 4.5mm, 12mm
16-32-4512

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 11mm. 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
16-32-4511
In Commercial Distribution

  • 10889981034412 ()

  • 4.5mm, 11mm
16-32-4511

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 10mm. 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
16-32-4510
In Commercial Distribution

  • 10889981034405 ()

  • 4.5mm, 10mm
16-32-4510

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 9mm. 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
16-32-4509
In Commercial Distribution

  • 10889981034399 ()

  • 4.5mm, 9mm
16-32-4509

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 8mm. 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
16-32-4508
In Commercial Distribution

  • 10889981034382 ()

  • 4.5mm, 8mm
16-32-4508

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 7mm. 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
16-32-4507
In Commercial Distribution

  • 10889981034375 ()

  • 4.5mm, 7mm
16-32-4507

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 6mm. 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
16-32-4506
In Commercial Distribution

  • 10889981034368 ()

  • 4.5mm, 6mm
16-32-4506

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm 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
16-32-4018
In Commercial Distribution

  • 10889981034351 ()

  • 4.0mm, 18mm
16-32-4018

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm 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
16-32-4017
In Commercial Distribution

  • 10889981034344 ()

  • 4.0mm, 17mm
16-32-4017

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm 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
16-32-4016
In Commercial Distribution

  • 10889981034337 ()

  • 4.0mm, 16mm
16-32-4016

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm 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
16-32-4015
In Commercial Distribution

  • 10889981034320 ()

  • 4.0mm, 15mm
16-32-4015

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm 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
16-32-4014
In Commercial Distribution

  • 10889981034313 ()

  • 4.0mm, 14mm
16-32-4014

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Self Tapping Occipital Screw, 13mm. 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
16-32-4013
In Commercial Distribution

  • 10889981034306 ()

  • 4.0mm, 13mm
16-32-4013

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Self Tapping Occipital Screw, 12mm. 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
16-32-4012
In Commercial Distribution

  • 10889981034290 ()

  • 4.0mm, 12mm
16-32-4012

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Self Tapping Occipital Screw, 11mm. 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
16-32-4011
In Commercial Distribution

  • 10889981034283 ()

  • 4.0mm, 11mm
16-32-4011

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Self Tapping Occipital Screw, 10mm. 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
16-32-4010
In Commercial Distribution

  • 10889981034276 ()

  • 4.0mm, 10mm
16-32-4010

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Self Tapping Occipital Screw, 9mm. 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
16-32-4009
In Commercial Distribution

  • 10889981034269 ()

  • 4.0mm, 9mm
16-32-4009

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Self Tapping Occipital Screw, 8mm. 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
16-32-4008
In Commercial Distribution

  • 10889981034252 ()

  • 4.0mm, 8mm
16-32-4008

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Self Tapping Occipital Screw, 7mm. 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
16-32-4007
In Commercial Distribution

  • 10889981034245 ()

  • 4.0mm, 7mm
16-32-4007

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Self Tapping Occipital Screw, 6mm. 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
16-32-4006
In Commercial Distribution

  • 10889981034238 ()

  • 4.0mm, 6mm
16-32-4006

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm 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
16-31-4518
Not in Commercial Distribution

  • 10889981034221 ()

  • 4.5mm, 18mm
16-31-4518

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm 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
16-31-4517
Not in Commercial Distribution

  • 10889981034214 ()

  • 4.5mm, 17mm
16-31-4517

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm 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
16-31-4516
Not in Commercial Distribution

  • 10889981034207 ()

  • 4.5mm, 16mm
16-31-4516

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