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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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Atoll™ - 10889981052171

3.5mm x 24mm Standard Screw. 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
16-10-3524
Not in Commercial Distribution

  • 10889981052171 ()

  • 3.5mm x 24mm
16-10-3524

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

Atoll™ - 10889981052164

3.5mm x 22mm Standard Screw. 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
16-10-3522
In Commercial Distribution

  • 10889981052164 ()

  • 3.5mm x 22mm
16-10-3522

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

Malibu - 10889981002640

Malibu Polyaxial Reduction Screw,7.5 x 85mm
SEASPINE ORTHOPEDICS CORPORATION
13-7585
Not in Commercial Distribution

  • 10889981002640 ()

  • 7.5 x 85mm
13-7585

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

Malibu - 10889981002633

Malibu Polyaxial Reduction Screw,7.5 x 80mm
SEASPINE ORTHOPEDICS CORPORATION
13-7580
Not in Commercial Distribution

  • 10889981002633 ()

  • 7.5 x 80mm
13-7580

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

Malibu - 10889981002626

Malibu Polyaxial Reduction Screw,7.5 x 75mm
SEASPINE ORTHOPEDICS CORPORATION
13-7575
Not in Commercial Distribution

  • 10889981002626 ()

  • 7.5 x 75mm
13-7575

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

Malibu - 10889981002619

Malibu Polyaxial Reduction Screw,7.5 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
13-7570
In Commercial Distribution

  • 10889981002619 ()

  • 7.5 x 70mm
13-7570

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

Malibu - 10889981002602

Malibu Polyaxial Reduction Screw,7.5 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
13-7565
In Commercial Distribution

  • 10889981002602 ()

  • 7.5 x 65mm
13-7565

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

Malibu - 10889981002572

Malibu Polyaxial Reduction Screw,7.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
13-7550
In Commercial Distribution

  • 10889981002572 ()

  • 7.5 x 50mm
13-7550

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

Malibu - 10889981002541

Malibu Polyaxial Reduction Screw,7.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
13-7535
In Commercial Distribution

  • 10889981002541 ()

  • 7.5 x 35mm
13-7535

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

Malibu - 10889981002510

Malibu Polyaxial Reduction Screw,7.5 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
13-7510
Not in Commercial Distribution

  • 10889981002510 ()

  • 7.5 x 110mm
13-7510

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