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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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0 Deg, Convex, Implant Caddy, Base, Oblique
MEDTRONIC SOFAMOR DANEK, INC.
3900-1003-05
In Commercial Distribution

  • 00191375051602 ()


  • Instrument tray, reusable
Convex, Odds, PLIF, Implant Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
3900-1002-10
In Commercial Distribution

  • 00191375051596 ()


  • Instrument tray, reusable
Convex, Odds, PLIF, Implant Caddy, Base
MEDTRONIC SOFAMOR DANEK, INC.
3900-1002-05
In Commercial Distribution

  • 00191375051589 ()


  • Instrument tray, reusable
0 Deg, Convex, Implant Caddy, Lid, Oblique
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-72
In Commercial Distribution

  • 00191375051572 ()


  • Instrument tray, reusable
0 Deg, Convex, Implant Caddy, Base, Oblique
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-71
In Commercial Distribution

  • 00191375051565 ()


  • Instrument tray, reusable
Evens, Lordotic, PLIF, Implant Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-62
In Commercial Distribution

  • 00191375051558 ()


  • Instrument tray, reusable
Evens, Lordotic, PLIF, Implant Caddy, Base
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-61
In Commercial Distribution

  • 00191375051541 ()


  • Instrument tray, reusable
Convex, Evens, PLIF, Implant Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-52
In Commercial Distribution

  • 00191375051534 ()


  • Instrument tray, reusable
Tray Implant Holder (base)
TITAN SPINE, LLC
3900-1001-10
Not in Commercial Distribution

  • 00191375051510 ()
3900-1001-10

  • Instrument tray, reusable
Trial, PLIF, 16mm
TITAN SPINE, LLC
3210-2216
Not in Commercial Distribution

  • 00191375032229 ()

  • Depth: 9 Millimeter
  • Height: 16 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Width: 22 Millimeter
3210-2216

  • Spinal implant trial
Trial, Oblique, 16mm
TITAN SPINE, LLC
3210-3116
Not in Commercial Distribution

  • 00191375031116 ()

  • width(MLxAP), 31 x 11, mm
  • Depth: 11 Millimeter
  • Height: 16 Millimeter
  • Width: 31 Millimeter
3210-3116

  • Spinal implant trial
Trial, Oblique, 14mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-3114
In Commercial Distribution

  • 00191375031093 ()

  • Depth: 11 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Height: 14 Millimeter
  • Width: 31 Millimeter


  • Spinal implant trial
Trial, Oblique, 12mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-3112
In Commercial Distribution

  • 00191375031079 ()

  • Depth: 11 Millimeter
  • Height: 12 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Width: 31 Millimeter


  • Spinal implant trial
Trial, Oblique, 8mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-3108
In Commercial Distribution

  • 00191375030188 ()

  • Height: 8 Millimeter
  • Depth: 11 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Width: 31 Millimeter


  • Spinal implant trial
Straight Tooth Rasp, 11mm
TITAN SPINE, LLC
3210-0002
Not in Commercial Distribution

  • 00191375028369 ()

  • Length: 14 Inch
  • Width: 11 Millimeter
3210-0002

  • Bone file/rasp, manual, reusable
Upper, Inner Tray
MEDTRONIC SOFAMOR DANEK, INC.
586-030-201
In Commercial Distribution

  • 00191375051862 ()


  • Instrument tray, reusable
Lower, Inner Tray
MEDTRONIC SOFAMOR DANEK, INC.
586-030-101
In Commercial Distribution

  • 00191375051855 ()


  • Instrument tray, reusable
Instrument Case
TITAN SPINE, LLC
586-000-001
Not in Commercial Distribution

  • 00191375051831 ()
586-000-001

  • Instrument tray, reusable
Convex, Evens, PLIF, Implant Caddy, Base
MEDTRONIC SOFAMOR DANEK, INC.
3900-1001-51
In Commercial Distribution

  • 00191375051527 ()


  • Instrument tray, reusable
Trial, Oblique, 15mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-3115
In Commercial Distribution

  • 00191375031109 ()

  • Depth: 11 Millimeter
  • Height: 15 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Width: 31 Millimeter


  • Spinal implant trial
Trial, Oblique, 13mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-3113
In Commercial Distribution

  • 00191375031086 ()

  • Height: 13 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Depth: 11 Millimeter
  • Width: 31 Millimeter


  • Spinal implant trial
Trial, Oblique, 11mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-3111
In Commercial Distribution

  • 00191375031062 ()

  • Height: 11 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Depth: 11 Millimeter
  • Width: 31 Millimeter


  • Spinal implant trial
Trial, Oblique, 10mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-3110
In Commercial Distribution

  • 00191375031055 ()

  • width(MLxAP), 31 x 11, mm
  • Width: 31 Millimeter
  • Height: 10 Millimeter
  • Depth: 11 Millimeter


  • Spinal implant trial
Trial, Oblique, 9mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-3109
In Commercial Distribution

  • 00191375031048 ()

  • Depth: 11 Millimeter
  • Height: 9 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Width: 31 Millimeter


  • Spinal implant trial
Straight Tooth Rasp, 9mm
TITAN SPINE, LLC
3210-0001
Not in Commercial Distribution

  • 00191375028352 ()

  • Length: 14 Inch
  • Width: 9 Millimeter
3210-0001

  • Bone file/rasp, manual, reusable
Odd Size Trays
TITAN SPINE, LLC
3900-1011
Not in Commercial Distribution

  • 00191375004981 ()

  • Length: 21 Inch
  • Width: 10 Inch
  • Height: 4 Inch
3900-1011

  • Instrument tray, reusable
Perforated Tray System
TITAN SPINE, LLC
3900-1001
Not in Commercial Distribution

  • 00191375004974 ()

  • Length: 21 Inch
  • Width: 10 Inch
  • Height: 4 Inch
3900-1001

  • Instrument tray, reusable
Trial, PLIF, 15mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2215
In Commercial Distribution

  • 00191375004967 ()

  • width(MLxAP), 22 x 9, mm
  • Depth: 9 Millimeter
  • Width: 22 Millimeter
  • Height: 15 Millimeter


  • Spinal implant trial
Trial, PLIF, 14mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2214
In Commercial Distribution

  • 00191375004950 ()

  • Width: 22 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Depth: 9 Millimeter
  • Height: 14 Millimeter


  • Spinal implant trial
Trial, PLIF, 13mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2213
In Commercial Distribution

  • 00191375004943 ()

  • width(MLxAP), 22 x 9, mm
  • Width: 22 Millimeter
  • Depth: 9 Millimeter
  • Height: 13 Millimeter


  • Spinal implant trial
Trial, PLIF, 12mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2212
In Commercial Distribution

  • 00191375004936 ()

  • Width: 22 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Depth: 9 Millimeter
  • Height: 12 Millimeter


  • Spinal implant trial
Trial, PLIF, 11mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2211
In Commercial Distribution

  • 00191375004929 ()

  • Depth: 9 Millimeter
  • Width: 22 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Height: 11 Millimeter


  • Spinal implant trial
Trial, PLIF, 10mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2210
In Commercial Distribution

  • 00191375004912 ()

  • Width: 22 Millimeter
  • Depth: 9 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Height: 10 Millimeter


  • Spinal implant trial
Trial, PLIF, 9mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2209
In Commercial Distribution

  • 00191375004905 ()

  • Width: 22 Millimeter
  • Depth: 9 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Height: 9 Millimeter


  • Spinal implant trial
Trial, PLIF, 8mm
MEDTRONIC SOFAMOR DANEK, INC.
3210-2208
In Commercial Distribution

  • 00191375004899 ()

  • Depth: 9 Millimeter
  • Width: 22 Millimeter
  • width(MLxAP), 22 x 9, mm
  • Height: 8 Millimeter


  • Spinal implant trial
Remover Implant, Threaded
MEDTRONIC SOFAMOR DANEK, INC.
3200-4000
In Commercial Distribution

  • 00191375004882 ()

  • Length: 13 Inch


  • Orthopaedic inorganic implant inserter/extractor, reusable
Interbody Fusion Device 4 Degree Oblique 16mm
TITAN SPINE, LLC
3114-3116
Not in Commercial Distribution

  • 00191375004875 ()

  • Depth: 11 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Angle: 4 degree
  • Width: 31 Millimeter
  • Lordotic Angle 4 Deg
  • Height: 16 Millimeter
3114-3116

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 4 Degree Oblique 15mm
TITAN SPINE, LLC
3114-3115
Not in Commercial Distribution

  • 00191375004868 ()

  • Width: 31 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Angle: 4 degree
  • Depth: 11 Millimeter
  • Lordotic Angle 4 Deg
  • Height: 15 Millimeter
3114-3115

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 4 Degree Oblique 14mm
TITAN SPINE, LLC
3114-3114
Not in Commercial Distribution

  • 00191375004851 ()

  • Lordotic Angle 4 Deg
  • Height: 14 Millimeter
  • Depth: 11 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Angle: 4 degree
  • Width: 31 Millimeter
3114-3114

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 4 Degree Oblique 13mm
TITAN SPINE, LLC
3114-3113
Not in Commercial Distribution

  • 00191375004844 ()

  • Depth: 11 Millimeter
  • width(MLxAP), 31 x 11, mm
  • Angle: 4 degree
  • Width: 31 Millimeter
  • Lordotic Angle 4 Deg
  • Height: 13 Millimeter
3114-3113

  • Metallic spinal interbody fusion cage
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