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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Dual Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP2251 ()
  • M719GBP2250 ()

  • Length: 25 Millimeter
GBP2-25

  • Bone-screw internal spinal fixation system, non-sterile
Single Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP1250 ()
  • M719GBP1251 ()

  • Length: 25 Millimeter
GBP1-25

  • Bone-screw internal spinal fixation system, non-sterile
Screw Caddy, Xpress, 5.5mm
Xtant Medical Holdings, Inc.
X073-0011
In Commercial Distribution

  • M697X07300110 ()
  • M697X07300111 ()

  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod Template, 5.5mm x 400mm
Xtant Medical Holdings, Inc.
X067-0652
In Commercial Distribution

  • M697X06706520 ()
  • M697X06706521 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 400 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
5.5 DUAL LEAD, CANNULATED TAP
Xtant Medical Holdings, Inc.
T073-0500-55-DL
In Commercial Distribution

  • M697T073050055DL0 ()
  • M697T073050055DL1 ()

  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
5.5 CANNULATED TAP
Xtant Medical Holdings, Inc.
T073-0500-55
In Commercial Distribution

  • M697T0730500550 ()
  • M697T0730500551 ()

  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
5.5mm SPECIALTY AGGRESSIVE TIP CANNULATED DOUBLE LEAD TAPS
Xtant Medical Holdings, Inc.
C073-0075
In Commercial Distribution

  • M697C07300750 ()
  • M697C07300751 ()

  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
5.5mm Dual Lead Tap, Cannulated
Xtant Medical Holdings, Inc.
C073-0095
In Commercial Distribution

  • M697C07300950 ()
  • M697C07300951 ()

  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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
5509 SERIES STRAIGHT ROD MIS - COBALT CHROME, 5.5MM X 65MM
CORELINK LLC
R5509-065
In Commercial Distribution

  • M725R5509065 ()

  • Length: 65 Millimeter
  • Outer Diameter: 5.5 Millimeter
R5509-065

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