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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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ARRAY® SPINAL SYSTEM - 00880304914834

No Description
BIOMET SPINE LLC
94420J
In Commercial Distribution

  • 00880304914834 ()

  • TI ALLOY 5.5MM DIA X 610MM ROD WITH LINE
94420J

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

Polaris™ 5.5 Spinal System - 00880304914827

No Description
BIOMET SPINE LLC
94487
In Commercial Distribution

  • 00880304914827 ()

  • 16MM FIXED CROSS CONNECTOR
94487

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

Polaris™ 5.5 Spinal System - 00880304914810

No Description
BIOMET SPINE LLC
94488
In Commercial Distribution

  • 00880304914810 ()

  • 18MM FIXED CROSS CONNECTOR
94488

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

Polaris™ 5.5 Spinal System - 00880304914780

No Description
BIOMET SPINE LLC
94491
In Commercial Distribution

  • 00880304914780 ()

  • 24MM FIXED CROSS CONNECTOR
94491

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

Polaris™ 5.5 Spinal System - 00880304914360

No Description
BIOMET SPINE LLC
2000-5405E
In Commercial Distribution

  • 00880304914360 ()

  • 510 mm Ti Alloy Rod w/ Hex
2000-5405E

  • Bone-screw internal spinal fixation system, sterile

Polaris™ 5.5 Spinal System - 00880304914353

No Description
BIOMET SPINE LLC
2000-5305E
In Commercial Distribution

  • 00880304914353 ()

  • 510 mm CP Ti Rod w/ Hex
2000-5305E

  • Bone-screw internal spinal fixation system, sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304916579

No Description
BIOMET SPINE LLC
2000-7661
In Commercial Distribution

  • 00880304916579 ()

  • 8.5MM X 60MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD
2000-7661

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

POLARIS™ 5.5 SPINAL SYSTEM - 00880304916562

No Description
BIOMET SPINE LLC
2000-7665
In Commercial Distribution

  • 00880304916562 ()

  • 8.5X65MM MULTIAXIAL RED.SCREW
2000-7665

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

POLARIS™ 5.5 SPINAL SYSTEM - 00880304916555

No Description
BIOMET SPINE LLC
2000-7665C
In Commercial Distribution

  • 00880304916555 ()

  • SCREW, 8.5MM X 65MM MULTIAXIAL CANNULATED REDUCTION
2000-7665C

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

POLARIS™ 5.5 SPINAL SYSTEM - 00880304916548

No Description
BIOMET SPINE LLC
2000-7666
In Commercial Distribution

  • 00880304916548 ()

  • 8.5MM X 65MM REDUCTION SCREW MULTIAXIAL, DOUBLE LEAD
2000-7666

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