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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 Device Size Type Device Class Implantable

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Black Diamond Pedicle Screw System - B062100100000J

The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Osseus Fusion Systems, LLC
1001-0000
In Commercial Distribution

  • 71341402JV ()
  • B062100100000J ()

  • Length: 300 Millimeter
  • Length: 250 Millimeter
  • Length: 200 Millimeter
  • Length: 120 Millimeter
  • Length: 115 Millimeter
  • Length: 110 Millimeter
  • Length: 105 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
  • Outer Diameter: 8.5 Millimeter
  • Outer Diameter: 7.5 Millimeter
  • Outer Diameter: 6.5 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Depth: 90 Millimeter
  • Depth: 70 Millimeter
  • Depth: 50 Millimeter
  • Depth: 35 Millimeter
  • Depth: 30 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
  • Length: 65 Millimeter
  • Length: 70 Millimeter
  • Length: 75 Millimeter
  • Length: 80 Millimeter
  • Length: 85 Millimeter
  • Length: 90 Millimeter
  • Length: 95 Millimeter
  • Length: 100 Millimeter
1001-0000 to 1010-9999

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

Excella II® - M711SR55450

Ti 6Al 4V (ELI)
Innovasis, Inc.
SR5545
In Commercial Distribution

  • M711SR55450 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter
SR5545

  • Bone-screw internal spinal fixation system rod

Excella III-D® - M711RE375450

Ti 6Al 4V (ELI)
Innovasis, Inc.
RE37545
In Commercial Distribution

  • M711RE375450 ()

  • Length: 45 Millimeter
  • Outer Diameter: 7.5 Millimeter
RE37545

  • Spinal bone screw, non-bioabsorbable

Excella III-D® - M711RE365450

Ti 6Al 4V (ELI)
Innovasis, Inc.
RE36545
In Commercial Distribution

  • M711RE365450 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 45 Millimeter
RE36545

  • Spinal bone screw, non-bioabsorbable

Excella III-D® - M711RE355450

Ti 6Al 4V (ELI)
Innovasis, Inc.
RE35545
In Commercial Distribution

  • M711RE355450 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter
RE35545

  • Spinal bone screw, non-bioabsorbable

Excella II® - M711PR55450

Ti 6Al 4V (ELI)
Innovasis, Inc.
PR5545
In Commercial Distribution

  • M711PR55450 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter
PR5545

  • Bone-screw internal spinal fixation system rod

Excella MIS™ - M711MSR55450

Ti 6Al 4V (ELI)
Innovasis, Inc.
MSR5545
In Commercial Distribution

  • M711MSR55450 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter
MSR5545

  • Bone-screw internal spinal fixation system rod

Excella MIS® - M711MPRL55450

Ti 6Al 4V (ELI)
Innovasis, Inc.
MPRL5545
In Commercial Distribution

  • M711MPRL55450 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter
MPRL5545

  • Bone-screw internal spinal fixation system rod

Excella MIS™ - M711MPR55450

Ti 6Al 4V (ELI)
Innovasis, Inc.
MPR5545
In Commercial Distribution

  • M711MPR55450 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter
MPR5545

  • Bone-screw internal spinal fixation system rod

TIGER Spine System - M7255528545

5500 SERIES REDUCTION SCREW - 8.5MM X 45MM
CORELINK LLC
55285-45
In Commercial Distribution

  • M7255528545 ()

  • Length: 45 Millimeter
  • Outer Diameter: 8.5 Millimeter
55285-45

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