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
CALIBRATED GUIDE PIN 3.2MM X 400MM
ORTHOPAEDIC IMPLANT COMPANY, THE
32-400P
Not in Commercial Distribution

  • M69632400P1 ()
  • M69632400P0 ()


  • Orthopaedic bone pin, non-bioabsorbable
K-Wire Holding Block
NEXUS SPINE, L.L.C.
820353
Not in Commercial Distribution

  • B6788203530 ()


  • Bone-screw internal spinal fixation system, sterile
Retractor Foot
NEXUS SPINE, L.L.C.
820352
Not in Commercial Distribution

  • B6788203520 ()


  • Bone-screw internal spinal fixation system, sterile
Retractor Foot Locker / Unlocker
NEXUS SPINE, L.L.C.
820351
Not in Commercial Distribution

  • B6788203510 ()


  • Bone-screw internal spinal fixation system, sterile
MIS Interlagos Retractor Main Frame Assembly
NEXUS SPINE, L.L.C.
820343
Not in Commercial Distribution

  • B6788203430 ()


  • Bone-screw internal spinal fixation system, sterile
PressOn Straight Steffee Probe – Palm Handle
NEXUS SPINE, L.L.C.
820338PH
Not in Commercial Distribution

  • B678820338PH0 ()


  • Bone-screw internal spinal fixation system, sterile
PressOn Straight Steffee Probe – Ball Handle (1.8”)
NEXUS SPINE, L.L.C.
820338BH
Not in Commercial Distribution

  • B678820338BH0 ()


  • Bone-screw internal spinal fixation system, sterile
PressOn Curved Steffee Probe – Palm Handle
NEXUS SPINE, L.L.C.
820337PH
Not in Commercial Distribution

  • B678820337PH0 ()


  • Bone-screw internal spinal fixation system, sterile
PressOn Curved Steffee Probe – Ball Handle (1.8”)
NEXUS SPINE, L.L.C.
820337BH
Not in Commercial Distribution

  • B678820337BH0 ()


  • Bone-screw internal spinal fixation system, sterile
PressOn Straight Lenke Probe – Palm Handle
NEXUS SPINE, L.L.C.
820336PH
Not in Commercial Distribution

  • B678820336PH0 ()


  • Bone-screw internal spinal fixation system, sterile
PressOn Straight Lenke Probe – Ball Handle (1.8”)
NEXUS SPINE, L.L.C.
820336BH
Not in Commercial Distribution

  • B678820336BH0 ()


  • Bone-screw internal spinal fixation system, sterile
Kolbel Retractor
NEXUS SPINE, L.L.C.
820336
Not in Commercial Distribution

  • B6788203360 ()


  • Bone-screw internal spinal fixation system, sterile
Quick Start Distractor Screw, 14 mm, Sterile, 5/box
NEXUS SPINE, L.L.C.
820334
Not in Commercial Distribution

  • B6788203340 ()

  • Length: 14 Millimeter


  • Bone-screw internal spinal fixation system, sterile
PressOn Curved Lenke Probe – Palm Handle
NEXUS SPINE, L.L.C.
820332PH
Not in Commercial Distribution

  • B678820332PH0 ()


  • Bone-screw internal spinal fixation system, sterile
PressON Curved Lenke Probe - Ball Handle (1.8")
NEXUS SPINE, L.L.C.
820332BH
Not in Commercial Distribution

  • B678820332BH0 ()


  • Bone-screw internal spinal fixation system, sterile
Quick Start Distractor Screw, 12 mm, Sterile, 5/box
NEXUS SPINE, L.L.C.
820329
Not in Commercial Distribution

  • B6788203290 ()

  • Length: 12 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Locking Distractor, Hinged, 80 mm Arms, Left, 120 mm Rack (CS-0138)
NEXUS SPINE, L.L.C.
820328
Not in Commercial Distribution

  • B6788203280 ()


  • Bone-screw internal spinal fixation system, sterile
Altus Interlagos Light Cable (600-3111)
NEXUS SPINE, L.L.C.
820327
Not in Commercial Distribution

  • B6788203270 ()


  • Bone-screw internal spinal fixation system, sterile
Guidewire Puller (gS 82.0230)
NEXUS SPINE, L.L.C.
820324
Not in Commercial Distribution

  • B6788203240 ()


  • Bone-screw internal spinal fixation system, sterile
Reversible Blade, 90x25mm
NEXUS SPINE, L.L.C.
820322.08
Not in Commercial Distribution

  • B678820322080 ()

  • Width: 25 Millimeter
  • Length: 90 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Reversible Blade, 80x25mm
NEXUS SPINE, L.L.C.
820322.07
Not in Commercial Distribution

  • B678820322070 ()

  • Width: 25 Millimeter
  • Length: 80 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Lat Bld, Interlagos 25x70mm, HC
NEXUS SPINE, L.L.C.
820322.06
Not in Commercial Distribution

  • B678820322060 ()

  • Width: 25 Millimeter
  • Length: 70 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Lat Bld, Interlagos 25x60mm, HC
NEXUS SPINE, L.L.C.
820322.05
Not in Commercial Distribution

  • B678820322050 ()

  • Width: 25 Millimeter
  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Reversible Blade, 90x15mm
NEXUS SPINE, L.L.C.
820322.04
In Commercial Distribution

  • B678820322040 ()

  • Width: 15 Millimeter
  • Length: 90 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Reversible Blade, 80x15mm
NEXUS SPINE, L.L.C.
820322.03
Not in Commercial Distribution

  • B678820322030 ()

  • Width: 15 Millimeter
  • Length: 80 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Lat Bld, Interlagos 15x70mm, HC
NEXUS SPINE, L.L.C.
820322.02
Not in Commercial Distribution

  • B678820322020 ()

  • Width: 15 Millimeter
  • Length: 70 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Lat Bld, Interlagos 15x60mm, HC
NEXUS SPINE, L.L.C.
820322.01
Not in Commercial Distribution

  • B678820322010 ()

  • Width: 15 Millimeter
  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, sterile
MIS Interlagos Retractor - 4th Blade Set
NEXUS SPINE, L.L.C.
820322
Not in Commercial Distribution

  • B6788203220 ()


  • Bone-screw internal spinal fixation system, sterile
4th Blade Slider Assy IL Retr
NEXUS SPINE, L.L.C.
820321.02
Not in Commercial Distribution

  • B678820321020 ()


  • Bone-screw internal spinal fixation system, sterile
4th Blade Rack Interlagos Retr
NEXUS SPINE, L.L.C.
820321.01
Not in Commercial Distribution

  • B678820321010 ()


  • Bone-screw internal spinal fixation system, sterile
MIS Interlagos Retractor - 4th Arm Frame and Blade Attachment
NEXUS SPINE, L.L.C.
820321
Not in Commercial Distribution

  • B6788203210 ()


  • Bone-screw internal spinal fixation system, sterile
Blade Retainer
NEXUS SPINE, L.L.C.
820319.25
Not in Commercial Distribution

  • B678820319250 ()


  • Bone-screw internal spinal fixation system, sterile
Handle Short Rachet Hudson
NEXUS SPINE, L.L.C.
820319.24
Not in Commercial Distribution

  • B678820319240 ()


  • Bone-screw internal spinal fixation system, sterile
Graphic Case, Interlagos
NEXUS SPINE, L.L.C.
820319.23
Not in Commercial Distribution

  • B678820319230 ()


  • Bone-screw internal spinal fixation system, sterile
Medial Blade, 100mm
NEXUS SPINE, L.L.C.
820319.22
Not in Commercial Distribution

  • B678820319220 ()

  • Length: 100 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Medial Blade, 90mm
NEXUS SPINE, L.L.C.
820319.21
Not in Commercial Distribution

  • B678820319210 ()

  • Length: 90 Millimeter


  • Bone-screw internal spinal fixation system, sterile
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