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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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Daytona® Small Stature - 10889981185114

Precontoured Ti Rod, 4.5 x 130mm
SEASPINE ORTHOPEDICS CORPORATION
78-0130
In Commercial Distribution

  • 10889981185114 ()
78-0130

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

Daytona® Small Stature - 10889981185091

Precontoured Ti Rod, 4.5 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
78-0110
In Commercial Distribution

  • 10889981185091 ()
78-0110

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

Daytona® Small Stature - 10889981185077

Precontoured Ti Rod, 4.5 x 90mm
SEASPINE ORTHOPEDICS CORPORATION
78-0090
In Commercial Distribution

  • 10889981185077 ()
78-0090

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

Daytona® Small Stature - 10889981185053

Precontoured Ti Rod, 4.5 x 70mm
SEASPINE ORTHOPEDICS CORPORATION
78-0070
In Commercial Distribution

  • 10889981185053 ()
78-0070

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

Daytona® Small Stature - 10889981185039

Precontoured Ti Rod, 4.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
78-0050
In Commercial Distribution

  • 10889981185039 ()
78-0050

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

Daytona® Small Stature - 10889981185015

Precontoured Ti Rod, 4.5 x 35mm
SEASPINE ORTHOPEDICS CORPORATION
78-0035
In Commercial Distribution

  • 10889981185015 ()
78-0035

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

UCR - 10889981036201

PEDICLE 9.0 X 5.0 MM
SEASPINE ORTHOPEDICS CORPORATION
14-9050
In Commercial Distribution

  • 10889981036201 ()

  • 9.0 X 5.0 MM
14-9050

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

UCR - 10889981036188

LAMINAR 7.0 X 6.5 MM
SEASPINE ORTHOPEDICS CORPORATION
14-7065
In Commercial Distribution

  • 10889981036188 ()

  • 7.0 X 6.5 MM
14-7065

  • 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
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