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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 - 10889981033941

Small Occipital Plate (25-35mm). 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
16-30-2535
In Commercial Distribution

  • 10889981033941 ()

  • small, 25-35mm
16-30-2535

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

Malibu™ - 10889981030834

PRECONTOURED ESS PLUS ROD, 5.5 x 600 mm
SEASPINE ORTHOPEDICS CORPORATION
15-3600
Not in Commercial Distribution

  • 10889981030834 ()

  • 5.5mm x 600 mm
15-3600

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

Malibu™ - 10889981030810

PRECONTOURED ESS PLUS ROD, 5.5 x 400 mm
SEASPINE ORTHOPEDICS CORPORATION
15-3400
In Commercial Distribution

  • 10889981030810 ()

  • 5.5mm x 400 mm
15-3400

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

NewPort™ - 10889981030605

70mm NewPort MIS Rod
SEASPINE ORTHOPEDICS CORPORATION
60-0470
In Commercial Distribution

  • 10889981030605 ()

  • 70mm
60-0470

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

NewPort™ - 10889981030599

65mm NewPort MIS Rod
SEASPINE ORTHOPEDICS CORPORATION
60-0465
In Commercial Distribution

  • 10889981030599 ()

  • 65mm
60-0465

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

NewPort™ - 10889981030582

60mm NewPort MIS Rod
SEASPINE ORTHOPEDICS CORPORATION
60-0460
In Commercial Distribution

  • 10889981030582 ()

  • 60mm
60-0460

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

NewPort™ - 10889981030575

55mm NewPort MIS Rod
SEASPINE ORTHOPEDICS CORPORATION
60-0455
In Commercial Distribution

  • 10889981030575 ()

  • 55mm
60-0455

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

NewPort™ - 10889981030568

50mm NewPort MIS Rod
SEASPINE ORTHOPEDICS CORPORATION
60-0450
In Commercial Distribution

  • 10889981030568 ()

  • 50mm
60-0450

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

NewPort™ - 10889981030551

45mm NewPort MIS Rod
SEASPINE ORTHOPEDICS CORPORATION
60-0445
In Commercial Distribution

  • 10889981030551 ()

  • 45mm
60-0445

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

NewPort™ - 10889981030544

40mm NewPort MIS Rod
SEASPINE ORTHOPEDICS CORPORATION
60-0440
In Commercial Distribution

  • 10889981030544 ()

  • 40mm
60-0440

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