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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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Locking Cap
Kalitec Direct LLC
11-LCL-0000
In Commercial Distribution

  • B07311LCL00000 ()
  • B07311LCL00002 ()
  • B07311LCL00001 ()


  • Spinal bone set screw
No Description
Innovasis, Inc.
EP0001
In Commercial Distribution

  • M711EP00014 ()
  • M711EP00011 ()
EP0001

  • Spinal bone screw, non-bioabsorbable
No Description
Innovasis, Inc.
E2002
In Commercial Distribution

  • M711E20024 ()
  • M711E20021 ()
E2002

  • Spinal bone screw, non-bioabsorbable
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
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 55
Xtant Medical Holdings, Inc.
X022-7555SD-DL
In Commercial Distribution

  • M697X0227555SDDL1 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 55 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 7.5 x 55 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-7555SD
In Commercial Distribution

  • M697X0227555SD1 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 55 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 50
Xtant Medical Holdings, Inc.
X022-7550SD-DL
In Commercial Distribution

  • M697X0227550SDDL1 ()

  • Length: 50 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 7.5 x 50 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-7550SD
In Commercial Distribution

  • M697X0227550SD1 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 45
Xtant Medical Holdings, Inc.
X022-7545SD-DL
In Commercial Distribution

  • M697X0227545SDDL1 ()

  • Length: 45 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 7.5 x 45 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-7545SD
In Commercial Distribution

  • M697X0227545SD1 ()

  • Length: 45 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 40
Xtant Medical Holdings, Inc.
X022-7540SD-DL
In Commercial Distribution

  • M697X0227540SDDL1 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 40 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 7.5 x 40 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-7540SD
In Commercial Distribution

  • M697X0227540SD1 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 40 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 35
Xtant Medical Holdings, Inc.
X022-7535SD-DL
In Commercial Distribution

  • M697X0227535SDDL1 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 7.5 x 35 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-7535SD
In Commercial Distribution

  • M697X0227535SD1 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 30
Xtant Medical Holdings, Inc.
X022-7530SD-DL
In Commercial Distribution

  • M697X0227530SDDL1 ()

  • Length: 30 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
No Description
Xtant Medical Holdings, Inc.
X022-7530SD
In Commercial Distribution

  • M697X0227530SD1 ()

  • Length: 30 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 55
Xtant Medical Holdings, Inc.
X022-6555SD-DL
In Commercial Distribution

  • M697X0226555SDDL1 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 55 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 6.5 x 55 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-6555SD
In Commercial Distribution

  • M697X0226555SD1 ()

  • Length: 55 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 50
Xtant Medical Holdings, Inc.
X022-6550SD-DL
In Commercial Distribution

  • M697X0226550SDDL1 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 6.5 x 50 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-6550SD
In Commercial Distribution

  • M697X0226550SD1 ()

  • Length: 50 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 45
Xtant Medical Holdings, Inc.
X022-6545SD-DL
In Commercial Distribution

  • M697X0226545SDDL1 ()

  • Length: 45 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 6.5 x 45 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-6545SD
In Commercial Distribution

  • M697X0226545SD1 ()

  • Length: 45 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex,DUAL LEAD, SELF-DRILLING SCREW 6.5 x 40
Xtant Medical Holdings, Inc.
X022-6540SD-DL
In Commercial Distribution

  • M697X0226540SDDL1 ()

  • Length: 40 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 6.5 x 40 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-6540SD
In Commercial Distribution

  • M697X0226540SD1 ()

  • Length: 40 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 35
Xtant Medical Holdings, Inc.
X022-6535SD-DL
In Commercial Distribution

  • M697X0226535SDDL1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 6.5 x 35 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-6535SD
In Commercial Distribution

  • M697X0226535SD1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 30
Xtant Medical Holdings, Inc.
X022-6530SD-DL
In Commercial Distribution

  • M697X0226530SDDL1 ()

  • Length: 30 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 6.5 x 30 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-6530SD
In Commercial Distribution

  • M697X0226530SD1 ()

  • Length: 30 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 55
Xtant Medical Holdings, Inc.
X022-5555SD-DL
In Commercial Distribution

  • M697X0225555SDDL1 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 5.5 x 55 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X022-5555SD
In Commercial Distribution

  • M697X0225555SD1 ()

  • Length: 55 Millimeter
  • Outer Diameter: 5.5 Millimeter


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