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 ()


  • 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
No Description
Innovasis, Inc.
E2002
In Commercial Distribution

  • M711E20024 ()
  • M711E20021 ()
E2002

  • Spinal bone screw, non-bioabsorbable
No Description
Innovasis, Inc.
EP0001
In Commercial Distribution

  • M711EP00014 ()
  • M711EP00011 ()
EP0001

  • Spinal bone screw, non-bioabsorbable
Wide Tip Hook
UNIFIED SPINE, LLC
501217
In Commercial Distribution

  • M9935012171 ()

  • Wide Tip Hook for 5.5mm Rod, Large


  • Bone-screw internal spinal fixation system, non-sterile
Wide Tip Hook
UNIFIED SPINE, LLC
501217
In Commercial Distribution

  • M9935012170 ()

  • Wide Tip Hook for 5.5mm Rod, Large


  • Bone-screw internal spinal fixation system, non-sterile
Wide Tip Hook
UNIFIED SPINE, LLC
501216
In Commercial Distribution

  • M9935012161 ()

  • Wide Tip Hook for 5.5mm Rod, Medium


  • Bone-screw internal spinal fixation system, non-sterile
Wide Tip Hook
UNIFIED SPINE, LLC
501216
In Commercial Distribution

  • M9935012160 ()

  • Wide Tip Hook for 5.5mm Rod, Medium


  • Bone-screw internal spinal fixation system, non-sterile
Wide Tip Hook
UNIFIED SPINE, LLC
501215
In Commercial Distribution

  • M9935012151 ()

  • Wide Tip Hook for 5.5mm Rod, Small


  • Bone-screw internal spinal fixation system, non-sterile
Wide Tip Hook
UNIFIED SPINE, LLC
501215
In Commercial Distribution

  • M9935012150 ()

  • Wide Tip Hook for 5.5mm Rod, Small


  • Bone-screw internal spinal fixation system, non-sterile
Standard Tip Hook
UNIFIED SPINE, LLC
501214
In Commercial Distribution

  • M9935012141 ()

  • Large Standard Tip Hook for 5.5mm Rod


  • Bone-screw internal spinal fixation system, non-sterile
Standard Tip Hook
UNIFIED SPINE, LLC
501214
In Commercial Distribution

  • M9935012140 ()

  • Large Standard Tip Hook for 5.5mm Rod


  • Bone-screw internal spinal fixation system, non-sterile
Standard Tip Hook
UNIFIED SPINE, LLC
501213
In Commercial Distribution

  • M9935012130 ()

  • Medium Standard Tip Hook for 5.5mm Rod


  • Bone-screw internal spinal fixation system, non-sterile
Standard Tip Hook
UNIFIED SPINE, LLC
501212
In Commercial Distribution

  • M9935012121 ()

  • Small Standard tip Hook for 5.5mm Rod


  • Bone-screw internal spinal fixation system, non-sterile
Standard Tip Hook
UNIFIED SPINE, LLC
501212
In Commercial Distribution

  • M9935012120 ()

  • Small Standard tip Hook for 5.5mm Rod


  • Bone-screw internal spinal fixation system, non-sterile
Set Screw for Rod System
UNIFIED SPINE, LLC
501125
In Commercial Distribution

  • M9935011251 ()

  • 3/8 inch -16 Class 3, 3 degree/45 degree Buttress Thread


  • Bone-screw internal spinal fixation system, non-sterile
Set Screw for 5mm Rod System
UNIFIED SPINE, LLC
501125
In Commercial Distribution

  • M9935011250 ()

  • 3/8 inch -16 Class 3, 3 degree/45 degree Buttress Thread


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Mulit-Axial Screw
UNIFIED SPINE, LLC
508793
In Commercial Distribution

  • M9975087931 ()

  • 7.5mm x 100mm Reduction Head Cannulated Mulit-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Mulit-Axial Screw
UNIFIED SPINE, LLC
508792
In Commercial Distribution

  • M9965087921 ()

  • 7.5mm x 95mm Reduction Head Cannulated Mulit-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Mulit-Axial Screw
UNIFIED SPINE, LLC
508791
In Commercial Distribution

  • M9955087911 ()

  • 7.5mm x 90mm Reduction Head Cannulated Mulit-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Mulit-Axial Screw
UNIFIED SPINE, LLC
508786
In Commercial Distribution

  • M9945087861 ()

  • 7.5mm x 85mm Reduction Head Cannulated Mulit-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Mulit-Axial Screw Assembly
UNIFIED SPINE, LLC
508796
In Commercial Distribution

  • M9935087961 ()

  • 7.5mm x 100mm Mulit-Axial Screw Assembly


  • Bone-screw internal spinal fixation system, non-sterile
Multi-Axial Screw Assembly
UNIFIED SPINE, LLC
508796
In Commercial Distribution

  • M9935087960 ()

  • 7.5mm x 100mm Multi-Axial Screw Assembly


  • Bone-screw internal spinal fixation system, non-sterile
Mulit-Axial Screw Assembly
UNIFIED SPINE, LLC
508795
In Commercial Distribution

  • M9935087951 ()

  • 7.5mm x 95mm Mulit-Axial Screw Assembly


  • Bone-screw internal spinal fixation system, non-sterile
Multi-Axial Screw Assembly
UNIFIED SPINE, LLC
508795
In Commercial Distribution

  • M9935087950 ()

  • 7.5mm x 95mm Multi-Axial Screw Assembly


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Multi-Axial Screw
UNIFIED SPINE, LLC
508793
In Commercial Distribution

  • M9935087930 ()

  • 7.5mm x 100mm Reduction Head Cannulated Multi-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Multi-Axial Screw
UNIFIED SPINE, LLC
508792
In Commercial Distribution

  • M9935087920 ()

  • 7.5mm x 95mm Reduction Head Cannulated Multi-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Multi-Axial Screw
UNIFIED SPINE, LLC
508791
In Commercial Distribution

  • M9935087910 ()

  • 7.5mm x 90mm Reduction Head Cannulated Multi-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Mulit-Axial Screw Assembly
UNIFIED SPINE, LLC
508790
In Commercial Distribution

  • M9935087901 ()

  • 7.5mm x 90mm Mulit-Axial Screw Assembly


  • Bone-screw internal spinal fixation system, non-sterile
Multi-Axial Screw Assembly
UNIFIED SPINE, LLC
508790
In Commercial Distribution

  • M9935087900 ()

  • 7.5mm x 90mm Multi-Axial Screw Assembly


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Multi-Axial Screw
UNIFIED SPINE, LLC
508786
In Commercial Distribution

  • M9935087860 ()

  • 7.5mm x 85mm Reduction Head Cannulated Multi-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Mulit-Axial Screw Assembly
UNIFIED SPINE, LLC
508785
In Commercial Distribution

  • M9935087851 ()

  • 7.5mm x 85mm Mulit-Axial Screw Assembly


  • Bone-screw internal spinal fixation system, non-sterile
Multi-Axial Screw Assembly
UNIFIED SPINE, LLC
508785
In Commercial Distribution

  • M9935087850 ()

  • 7.5mm x 85mm Multi-Axial Screw Assembly


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Mulit-Axial Screw
UNIFIED SPINE, LLC
508781
In Commercial Distribution

  • M9935087811 ()

  • 7.5mm x 80mm Reduction Head Cannulated Mulit-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Multi-Axial Screw
UNIFIED SPINE, LLC
508781
In Commercial Distribution

  • M9935087810 ()

  • 7.5mm x 80mm Reduction Head Cannulated Multi-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Mulit-Axial Screw Assembly
UNIFIED SPINE, LLC
508780
In Commercial Distribution

  • M9935087801 ()

  • 7.5mm x 80mm Mulit-Axial Screw Assembly


  • Bone-screw internal spinal fixation system, non-sterile
Multi-Axial Screw Assembly
UNIFIED SPINE, LLC
508780
In Commercial Distribution

  • M9935087800 ()

  • 7.5mm x 80mm Multi-Axial Screw Assembly


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Mulit-Axial Screw
UNIFIED SPINE, LLC
508776
In Commercial Distribution

  • M9935087761 ()

  • 7.5mm x 75mm Reduction Head Cannulated Mulit-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Reduction Head Cannulated Multi-Axial Screw
UNIFIED SPINE, LLC
508776
In Commercial Distribution

  • M9935087760 ()

  • 7.5mm x 75mm Reduction Head Cannulated Multi-Axial Screw


  • Bone-screw internal spinal fixation system, non-sterile
Mulit-Axial Screw Assembly
UNIFIED SPINE, LLC
508775
In Commercial Distribution

  • M9935087751 ()

  • 7.5mm x 75mm Mulit-Axial Screw Assembly


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