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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™ - 10889981052782

4.0mm x 24mm Smooth Shaft Poly Screw Assm. 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
16-13-4024
In Commercial Distribution

  • 10889981052782 ()

  • 4.0mm x 24mm
16-13-4024

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

Atoll™ - 10889981052775

4.0mm x 22mm Smooth Shaft Poly Screw Assm. 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
16-13-4022
In Commercial Distribution

  • 10889981052775 ()

  • 4.0mm x 22mm
16-13-4022

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

Atoll™ - 10889981052768

4.0mm x 20mm Smooth Shaft Poly Screw Assm. 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
16-13-4020
In Commercial Distribution

  • 10889981052768 ()

  • 4.0mm x 20mm
16-13-4020

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

Atoll™ - 10889981052751

4.0mm x 18mm Smooth Shaft Poly Screw Assm. 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
16-13-4018
In Commercial Distribution

  • 10889981052751 ()

  • 4.0mm x 18mm
16-13-4018

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

Atoll™ - 10889981052744

3.5mm x 38mm Smooth Shaft Poly Screw Assm. 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
16-13-3538
In Commercial Distribution

  • 10889981052744 ()

  • 3.5mm x 38mm
16-13-3538

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

Atoll™ - 10889981052737

3.5mm x 36mm Smooth Shaft Poly Screw Assm. 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
16-13-3536
In Commercial Distribution

  • 10889981052737 ()

  • 3.5mm x 36mm
16-13-3536

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

Atoll™ - 10889981052720

3.5mm x 34mm Smooth Shaft Poly Screw Assm. 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
16-13-3534
In Commercial Distribution

  • 10889981052720 ()

  • 3.5mm x 34mm
16-13-3534

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

Atoll™ - 10889981052713

3.5mm x 32mm Smooth Shaft Poly Screw Assm. 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
16-13-3532
In Commercial Distribution

  • 10889981052713 ()

  • 3.5mm x 32mm
16-13-3532

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

Atoll™ - 10889981052706

3.5mm x 30mm Smooth Shaft Poly Screw Assm. 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
16-13-3530
In Commercial Distribution

  • 10889981052706 ()

  • 3.5mm x 30mm
16-13-3530

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

Atoll™ - 10889981052690

3.5mm x 28mm Smooth Shaft Poly Screw Assm. 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
16-13-3528
In Commercial Distribution

  • 10889981052690 ()

  • 3.5mm x 28mm
16-13-3528

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

Atoll™ - 10889981052683

3.5mm x 26mm Smooth Shaft Poly Screw Assm. 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
16-13-3526
In Commercial Distribution

  • 10889981052683 ()

  • 3.5mm x 26mm
16-13-3526

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

Atoll™ - 10889981052676

3.5mm x 24mm Smooth Shaft Poly Screw Assm. 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
16-13-3524
In Commercial Distribution

  • 10889981052676 ()

  • 3.5mm x 24mm
16-13-3524

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

Atoll™ - 10889981052669

3.5mm x 22mm Smooth Shaft Poly Screw Assm. 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
16-13-3522
In Commercial Distribution

  • 10889981052669 ()

  • 3.5mm x 22mm
16-13-3522

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

Atoll™ - 10889981052652

3.5mm x 20mm Smooth Shaft Poly Screw Assm. 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
16-13-3520
In Commercial Distribution

  • 10889981052652 ()

  • 3.5mm x 20mm
16-13-3520

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

Atoll™ - 10889981052645

3.5mm x 18mm Smooth Shaft Poly Screw Assm. 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
16-13-3518
In Commercial Distribution

  • 10889981052645 ()

  • 3.5mm x 18mm
16-13-3518

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

Atoll™ - 10889981052638

4.5mm x 8mm Poly Screw Assm. 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
16-12-4508
In Commercial Distribution

  • 10889981052638 ()

  • 4.5mm x 8mm
16-12-4508

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

Atoll™ - 10889981052621

4.0mm x 50mm Poly Screw Assm. 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
16-12-4050
In Commercial Distribution

  • 10889981052621 ()

  • 4.0mm x 50mm
16-12-4050

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

Atoll™ - 10889981052614

4.0mm x 45mm Poly Screw Assm. 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
16-12-4045
In Commercial Distribution

  • 10889981052614 ()

  • 4.0mm x 45mm
16-12-4045

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

Atoll™ - 10889981052607

4.0mm x 40mm Poly Screw Assm. 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
16-12-4040
In Commercial Distribution

  • 10889981052607 ()

  • 4.0mm x 40mm
16-12-4040

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

Atoll™ - 10889981052591

4.0mm x 35mm Poly Screw Assm. 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
16-12-4035
In Commercial Distribution

  • 10889981052591 ()

  • 4.0mm x 35mm
16-12-4035

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

Atoll™ - 10889981052584

4.0mm x 30mm Poly Screw Assm. 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
16-12-4030
In Commercial Distribution

  • 10889981052584 ()

  • 4.0mm x 30mm
16-12-4030

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

Atoll™ - 10889981052577

4.0mm x 28mm Poly Screw Assm. 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
16-12-4028
In Commercial Distribution

  • 10889981052577 ()

  • 4.0mm x 28mm
16-12-4028

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

Atoll™ - 10889981052560

4.0mm x 26mm Poly Screw Assm. 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
16-12-4026
In Commercial Distribution

  • 10889981052560 ()

  • 4.0mm x 26mm
16-12-4026

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

Atoll™ - 10889981052553

4.0mm x 24mm Poly Screw Assm. 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
16-12-4024
In Commercial Distribution

  • 10889981052553 ()

  • 4.0mm x 24mm
16-12-4024

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

Atoll™ - 10889981052546

4.0mm x 22mm Poly Screw Assm. 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
16-12-4022
In Commercial Distribution

  • 10889981052546 ()

  • 4.0mm x 22mm
16-12-4022

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

Atoll™ - 10889981052539

4.0mm x 20mm Poly Screw Assm. 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
16-12-4020
In Commercial Distribution

  • 10889981052539 ()

  • 4.0mm x 20mm
16-12-4020

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

Atoll™ - 10889981052522

4.0mm x 18mm Poly Screw Assm. 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
16-12-4018
In Commercial Distribution

  • 10889981052522 ()

  • 4.0mm x 18mm
16-12-4018

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

Atoll™ - 10889981052515

4.0mm x 16mm Poly Screw Assm. 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
16-12-4016
In Commercial Distribution

  • 10889981052515 ()

  • 4.0mm x 16mm
16-12-4016

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

Atoll™ - 10889981052508

4.0mm x 14mm Poly Screw Assm. 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
16-12-4014
In Commercial Distribution

  • 10889981052508 ()

  • 4.0mm x 14mm
16-12-4014

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

Atoll™ - 10889981052492

4.0mm x 12mm Poly Screw Assm. 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
16-12-4012
In Commercial Distribution

  • 10889981052492 ()

  • 4.0mm x 12mm
16-12-4012

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