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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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Lineum® OCT Spine System - 00880304960145

No Description
BIOMET SPINE LLC
14-524010
In Commercial Distribution

  • 00880304960145 ()

  • LINEUM 3.5MM X 100MM TI ROD
14-524010

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

Lineum® OCT Spine System - 00880304960138

No Description
BIOMET SPINE LLC
14-524011
In Commercial Distribution

  • 00880304960138 ()

  • LINEUM 3.5MM X 100MM COCR ROD
14-524011

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

Lineum® OCT Spine System - 00880304960121

No Description
BIOMET SPINE LLC
14-524012
In Commercial Distribution

  • 00880304960121 ()

  • LINEUM 3.5MM X 120MM TI ROD
14-524012

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

POLARIS™ 5.5 SPINAL SYSTEM - 00880304965171

No Description
BIOMET SPINE LLC
14-512895R
In Commercial Distribution

  • 00880304965171 ()

  • 10.5MM X 95MM REDUCTION UNIPLANAR SCREW
14-512895R

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

POLARIS™ 5.5 SPINAL SYSTEM - 00880304965164

No Description
BIOMET SPINE LLC
14-512899R
In Commercial Distribution

  • 00880304965164 ()

  • 10.5MM X 100MM REDUCTION UNIPLANAR SCREW
14-512899R

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

Polaris™ 6.35 Spinal System - 00880304965157

No Description
BIOMET SPINE LLC
14-513120R
In Commercial Distribution

  • 00880304965157 ()

  • 4.0MM X 20MM REDUCTION UNIPLANAR SCREW
14-513120R

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

Polaris™ 6.35 Spinal System - 00880304965140

No Description
BIOMET SPINE LLC
14-513130R
In Commercial Distribution

  • 00880304965140 ()

  • 4.0MM X 30MM REDUCTION UNIPLANAR SCREW
14-513130R

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

Polaris™ 6.35 Spinal System - 00880304965133

No Description
BIOMET SPINE LLC
14-513135R
In Commercial Distribution

  • 00880304965133 ()

  • 4.0MM X 35MM REDUCTION UNIPLANAR SCREW
14-513135R

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

Polaris™ 6.35 Spinal System - 00880304965126

No Description
BIOMET SPINE LLC
14-513140R
In Commercial Distribution

  • 00880304965126 ()

  • 4.0MM X 40MM REDUCTION UNIPLANAR SCREW
14-513140R

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

Polaris™ 6.35 Spinal System - 00880304965119

No Description
BIOMET SPINE LLC
14-513145R
In Commercial Distribution

  • 00880304965119 ()

  • 4.0MM X 45MM REDUCTION UNIPLANAR SCREW
14-513145R

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