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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 Device Size Type Device Class Implantable

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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 - 10889981034498

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

Atoll - 10889981034481

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

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

Atoll - 10889981034436

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

Atoll - 10889981034429

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

Atoll - 10889981034412

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

Atoll - 10889981034405

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

Atoll - 10889981034399

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

Atoll - 10889981034382

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

Atoll - 10889981034375

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

Atoll - 10889981034368

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

Atoll - 10889981034351

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

Atoll - 10889981034344

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

Atoll - 10889981034337

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

Atoll - 10889981034320

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

Atoll - 10889981034313

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

Atoll - 10889981034306

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

Atoll - 10889981034290

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

Atoll - 10889981034283

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

Sierra™ - 10889981043940

Sierra Extended Tab Screw, 04.5 x 28mm
SEASPINE ORTHOPEDICS CORPORATION
51-4528
In Commercial Distribution

  • 10889981043940 ()

  • 4.5 Dia X 28mm
51-4528

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043933

Sierra Extended Tab Screw, 04.5 x 26mm
SEASPINE ORTHOPEDICS CORPORATION
51-4526
In Commercial Distribution

  • 10889981043933 ()

  • 4.5 Dia X 26mm
51-4526

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043575

Sierra Extended Tab Screw, 03.5 x 22mm
SEASPINE ORTHOPEDICS CORPORATION
51-3522
In Commercial Distribution

  • 10889981043575 ()

  • 3.5 Dia X 22mm
51-3522

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043537

Sierra Extended Tab Screw, 03.5 x 14mm
SEASPINE ORTHOPEDICS CORPORATION
51-3514
In Commercial Distribution

  • 10889981043537 ()

  • 3.5 Dia X 14mm
51-3514

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043513

Sierra Extended Tab Screw, 03.5 x 10mm
SEASPINE ORTHOPEDICS CORPORATION
51-3510
In Commercial Distribution

  • 10889981043513 ()

  • 3.5 Dia X 10mm
51-3510

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043506

Sierra Extended Tab Screw, 03.5 x 8mm
SEASPINE ORTHOPEDICS CORPORATION
51-3508
Not in Commercial Distribution

  • 10889981043506 ()

  • 3.5 Dia X 8mm
51-3508

  • Cannulated surgical drill bit, single-use
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