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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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SeaSpine NewPort Spinal System - 10889981138783

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

SeaSpine NewPort Spinal System - 10889981138813

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

SeaSpine NewPort Spinal System - 10889981138806

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

SeaSpine NewPort Spinal System - 10889981138790

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

SeaSpine NewPort Spinal System - 10889981138776

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

Specials - 10889981187699

Axial Hook Inserter
SEASPINE ORTHOPEDICS CORPORATION
SR-0406
In Commercial Distribution

  • 10889981187699 ()
SR-0406

  • Orthopaedic implant inserter/extractor, reusable

Mariner - 10889981182762

Reduction Screw Driver, Locking, Long
SEASPINE ORTHOPEDICS CORPORATION
90-1244
In Commercial Distribution

  • 10889981182762 ()
90-1244

  • Surgical screwdriver, reusable

Mariner - 10889981182755

Reduction Screw Driver, Locking, Short
SEASPINE ORTHOPEDICS CORPORATION
90-1243
In Commercial Distribution

  • 10889981182755 ()
90-1243

  • Surgical screwdriver, reusable

Mariner - 10889981182748

Reduction Screw Driver, Tri-Flat
SEASPINE ORTHOPEDICS CORPORATION
90-1242
In Commercial Distribution

  • 10889981182748 ()
90-1242

  • Surgical screwdriver, reusable

Mariner - 10889981182731

Reduction Screw Driver, Locking, A/O
SEASPINE ORTHOPEDICS CORPORATION
90-1241
In Commercial Distribution

  • 10889981182731 ()
90-1241

  • Surgical screwdriver, reusable

Mariner - 10889981182724

Reduction Screw Driver, Locking, Square Connect
SEASPINE ORTHOPEDICS CORPORATION
90-1240
In Commercial Distribution

  • 10889981182724 ()
90-1240

  • Surgical screwdriver, reusable

Mariner - 10889981182717

Quick Release Reducer
SEASPINE ORTHOPEDICS CORPORATION
90-0607
In Commercial Distribution

  • 10889981182717 ()
90-0607

  • Orthopaedic rod reducer

Specials - 10889984163072

Single Action Persuader
SEASPINE ORTHOPEDICS CORPORATION
SR-0314
Not in Commercial Distribution

  • 10889984163072 ()
SR-0314

  • Orthopaedic rod reducer

Specials - 10889981305123

Small Handle Cap Loader
SEASPINE ORTHOPEDICS CORPORATION
SR-0945
In Commercial Distribution

  • 10889981305123 ()
SR-0945

  • Orthopaedic implant inserter/extractor, reusable

Specials - 10889981303310

Extended Shank Driver Sleeve
SEASPINE ORTHOPEDICS CORPORATION
SR-0929
In Commercial Distribution

  • 10889981303310 ()
SR-0929

  • Orthopaedic implantation sleeve, reusable

Specials - 10889981303303

Extended Shank Driver
SEASPINE ORTHOPEDICS CORPORATION
SR-0928
In Commercial Distribution

  • 10889981303303 ()
SR-0928

  • Orthopaedic implant driver

Specials - 10889981303167

Tab Remover, Daytona
SEASPINE ORTHOPEDICS CORPORATION
SR-0867
In Commercial Distribution

  • 10889981303167 ()
SR-0867

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Specials - 10889981302382

Rod Rocker, Long - 13mm
SEASPINE ORTHOPEDICS CORPORATION
SR-0854
In Commercial Distribution

  • 10889981302382 ()
SR-0854

  • Orthopaedic rod reducer

Specials - 10889981163075

Single Action Persuader
SEASPINE ORTHOPEDICS CORPORATION
SR-0314
In Commercial Distribution

  • 10889981163075 ()
SR-0314

  • Orthopaedic rod reducer

General Instrument - 10889981158033

Head Inserter w/ Long Shaft
SEASPINE ORTHOPEDICS CORPORATION
SR-0249
In Commercial Distribution

  • 10889981158033 ()
SR-0249

  • Orthopaedic implant inserter/extractor, reusable

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
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