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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Interbody Fusion Device 7 Degree Standard 15mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-0115
In Commercial Distribution

  • 00191375001317 ()

  • Depth: 21 Millimeter
  • Width: 32 Millimeter
  • Angle: 7 degree
  • width(MLxAP), 32 x 21, mm
  • Lordotic Angle 7 Deg
  • Height: 15 Millimeter


  • Metallic spinal interbody fusion cage
Interbody Fusion Device 7 Degree Standard 14mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-0114
In Commercial Distribution

  • 00191375001300 ()

  • Width: 32 Millimeter
  • Depth: 21 Millimeter
  • width(MLxAP), 32 x 21, mm
  • Angle: 7 degree
  • Lordotic Angle 7 Deg
  • Height: 14 Millimeter


  • Metallic spinal interbody fusion cage
Interbody Fusion Device 7 Degree Standard 13mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-0113
In Commercial Distribution

  • 00191375001294 ()

  • Width: 32 Millimeter
  • Angle: 7 degree
  • Depth: 21 Millimeter
  • width(MLxAP), 32 x 21, mm
  • Lordotic Angle 7 Deg
  • Height: 13 Millimeter


  • Metallic spinal interbody fusion cage
Interbody Fusion Device 7 Degree Standard 12mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-0112
In Commercial Distribution

  • 00191375001287 ()

  • Angle: 7 degree
  • Depth: 21 Millimeter
  • width(MLxAP), 32 x 21, mm
  • Width: 32 Millimeter
  • Height: 12 Millimeter
  • Lordotic Angle 7 Deg


  • Metallic spinal interbody fusion cage
Interbody Fusion Device 7 Degree Standard 11mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-0111
In Commercial Distribution

  • 00191375001270 ()

  • Width: 32 Millimeter
  • width(MLxAP), 32 x 21, mm
  • Angle: 7 degree
  • Depth: 21 Millimeter
  • Lordotic Angle 7 Deg
  • Height: 11 Millimeter


  • Metallic spinal interbody fusion cage
Interbody Fusion Device 7 Degree Standard 10mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-0110
In Commercial Distribution

  • 00191375001263 ()

  • Depth: 21 Millimeter
  • Width: 32 Millimeter
  • Angle: 7 degree
  • width(MLxAP), 32 x 21, mm
  • Height: 10 Millimeter
  • Lordotic Angle 7 Deg


  • Metallic spinal interbody fusion cage
24 Deg Lordotic, Rasp, X-Large, 20mm
MEDTRONIC SOFAMOR DANEK, INC.
2324-7320
In Commercial Distribution

  • 00191375028215 ()

  • width(MLxAP), 40 x 27, mm
  • Width: 40 Millimeter
  • Angle: 24 degree
  • Depth: 27 Millimeter
  • Height: 20 Millimeter
  • Lordotic Angle 24 Deg


  • Bone file/rasp, manual, reusable
ZipGrip Handle w/Insulated Shaft, 5mm x 33 cm
FLEXBAR MACHINE CORPORATION
ZipGrip
In Commercial Distribution

  • 00842102116117 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
ZipClip Hook Scissor Tip, Disposable, Sterile
FLEXBAR MACHINE CORPORATION
ZipClip
In Commercial Distribution

  • 10842102116107 ()
  • 00842102116100 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
This product is intended for use in the control of the Randox Total Antioxidant Status assay,
RANDOX LABORATORIES LIMITED
NX2331
In Commercial Distribution

  • 05055273204728 ()
NX2331

  • Antioxidant capacity IVD, control
Bone Screw, 6.5mm x 35mm
MEDTRONIC SOFAMOR DANEK, INC.
2300-6535-S
In Commercial Distribution

  • 00191375029076 ()

  • Standard Bone Screw
  • 6.5mm Diameter, 35mm Length
  • Outer Diameter: 6.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Bone Screw, 5.5mm x 35mm
MEDTRONIC SOFAMOR DANEK, INC.
2300-5535-S
In Commercial Distribution

  • 00191375029069 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • 5.5mm Diameter, 35mm Length
  • Standard Bone Screw


  • Spinal bone screw, non-bioabsorbable
Bone Screw, 6.5mm x 30mm
MEDTRONIC SOFAMOR DANEK, INC.
2300-6530-S
In Commercial Distribution

  • 00191375027713 ()

  • Length: 30 Millimeter
  • Standard Bone Screw
  • Outer Diameter: 6.5 Millimeter
  • 6.5mm Diameter, 30mm Length


  • Spinal bone screw, non-bioabsorbable
Bone Screw, 6.5mm x 25mm
MEDTRONIC SOFAMOR DANEK, INC.
2300-6525-S
In Commercial Distribution

  • 00191375027706 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 25 Millimeter
  • 6.5mm Diameter, 25mm Length
  • Standard Bone Screw


  • Spinal bone screw, non-bioabsorbable
Bone Screw, 6.5mm x 20mm
MEDTRONIC SOFAMOR DANEK, INC.
2300-6520-S
In Commercial Distribution

  • 00191375027690 ()

  • Standard Bone Screw
  • 6.5mm Diameter, 20mm Length
  • Length: 20 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Bone Screw, 5.5mm x 30mm
MEDTRONIC SOFAMOR DANEK, INC.
2300-5530-S
In Commercial Distribution

  • 00191375027683 ()

  • Outer Diameter: 5.5 Millimeter
  • 5.5mm Diameter, 30mm Length
  • Length: 30 Millimeter
  • Standard Bone Screw


  • Spinal bone screw, non-bioabsorbable
Bone Screw, 5.5mm x 25mm
MEDTRONIC SOFAMOR DANEK, INC.
2300-5525-S
In Commercial Distribution

  • 00191375027676 ()

  • Outer Diameter: 5.5 Millimeter
  • 5.5mm Diameter, 25mm Length
  • Standard Bone Screw
  • Length: 25 Millimeter


  • Spinal bone screw, non-bioabsorbable
Bone Screw, 5.5mm x 20mm
MEDTRONIC SOFAMOR DANEK, INC.
2300-5520-S
In Commercial Distribution

  • 00191375027669 ()

  • Length: 20 Millimeter
  • Standard Bone Screw
  • Outer Diameter: 5.5 Millimeter
  • 5.5mm Diameter, 20mm Length


  • Spinal bone screw, non-bioabsorbable
Plate , Standard & Large, 18mm to 20mm
TITAN SPINE, LLC
2304-1821-S
Not in Commercial Distribution

  • 00191375038979 ()

  • Height: 20 Millimeter
  • For Use with Heights, 18mm to 20mm
  • Footprint, Standard & Large
  • Height: 19 Millimeter
  • Height: 18 Millimeter
2304-1821-S

  • Metallic spinal interbody fusion cage
Plate , Standard & Large, 14mm to 17mm
TITAN SPINE, LLC
2304-1417-S
Not in Commercial Distribution

  • 00191375038962 ()

  • Height: 14 Millimeter
  • Height: 15 Millimeter
  • Height: 16 Millimeter
  • Footprint, Standard & Large
  • For Use with Heights, 14mm to 17mm
  • Height: 17 Millimeter
2304-1417-S

  • Metallic spinal interbody fusion cage
Plate , Standard & Large, 12mm to 13mm
TITAN SPINE, LLC
2304-1013-S
Not in Commercial Distribution

  • 00191375038955 ()

  • For Use with Heights, 12mm to 13mm
  • Height: 13 Millimeter
  • Height: 12 Millimeter
  • Footprint, Standard & Large
2304-1013-S

  • Metallic spinal interbody fusion cage
Plate , X-Large, 18mm to 20mm
TITAN SPINE, LLC
2303-1821-S
Not in Commercial Distribution

  • 00191375038948 ()

  • Height: 18 Millimeter
  • Height: 19 Millimeter
  • Footprint, X-Large
  • Height: 20 Millimeter
  • For Use with Heights, 18mm to 20mm
2303-1821-S

  • Metallic spinal interbody fusion cage
Plate , X-Large, 14mm to 17mm
TITAN SPINE, LLC
2303-1417-S
Not in Commercial Distribution

  • 00191375038931 ()

  • Footprint, X-Large
  • For Use with Heights, 14mm to 17mm
  • Height: 15 Millimeter
  • Height: 14 Millimeter
  • Height: 17 Millimeter
  • Height: 16 Millimeter
2303-1417-S

  • Metallic spinal interbody fusion cage
Plate , X-Large, 12mm to 13mm
TITAN SPINE, LLC
2303-1013-S
Not in Commercial Distribution

  • 00191375038924 ()

  • Footprint, X-Large
  • For Use with Heights, 12mm to 13mm
  • Height: 12 Millimeter
  • Height: 13 Millimeter
2303-1013-S

  • Metallic spinal interbody fusion cage
Plate , Large, 18mm to 20mm
TITAN SPINE, LLC
2302-1821-S
Not in Commercial Distribution

  • 00191375038917 ()

  • Height: 20 Millimeter
  • Height: 19 Millimeter
  • Footprint, Large
  • Height: 18 Millimeter
  • For Use with Heights, 18mm to 20mm
2302-1821-S

  • Metallic spinal interbody fusion cage
Plate , Large, 14mm to 17mm
TITAN SPINE, LLC
2302-1417-S
Not in Commercial Distribution

  • 00191375038900 ()

  • Height: 17 Millimeter
  • Height: 14 Millimeter
  • Height: 15 Millimeter
  • Footprint, Large
  • Height: 16 Millimeter
  • For Use with Heights, 14mm to 17mm
2302-1417-S

  • Metallic spinal interbody fusion cage
Plate , Large, 12mm to 13mm
TITAN SPINE, LLC
2302-1013-S
Not in Commercial Distribution

  • 00191375038894 ()

  • For Use with Heights, 12mm to 13mm
  • Height: 12 Millimeter
  • Height: 13 Millimeter
  • Footprint, Large
2302-1013-S

  • Metallic spinal interbody fusion cage
Plate , Standard, 18mm to 20mm
TITAN SPINE, LLC
2301-1821-S
Not in Commercial Distribution

  • 00191375038887 ()

  • Height: 19 Millimeter
  • For Use with Heights, 18mm to 20mm
  • Footprint, Standard
  • Height: 18 Millimeter
  • Height: 20 Millimeter
2301-1821-S

  • Metallic spinal interbody fusion cage
Plate , Standard, 14mm to 17mm
TITAN SPINE, LLC
2301-1417-S
Not in Commercial Distribution

  • 00191375038870 ()

  • Footprint, Standard
  • Height: 15 Millimeter
  • For Use with Heights, 14mm to 17mm
  • Height: 16 Millimeter
  • Height: 17 Millimeter
  • Height: 14 Millimeter
2301-1417-S

  • Metallic spinal interbody fusion cage
Plate , Standard, 12mm to 13mm
TITAN SPINE, LLC
2301-1013-S
Not in Commercial Distribution

  • 00191375038863 ()

  • For Use with Heights, 12mm to 13mm
  • Height: 12 Millimeter
  • Footprint, Standard
  • Height: 13 Millimeter
2301-1013-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree X-Large 17mm
TITAN SPINE, LLC
2312-0317-S
Not in Commercial Distribution

  • 00191375021162 ()

  • Depth: 27 Millimeter
  • Angle: 12 degree
  • Width: 40 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Lordotic Angle 12 Deg
  • Height: 17 Millimeter
2312-0317-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree X-Large 16mm
TITAN SPINE, LLC
2312-0316-S
Not in Commercial Distribution

  • 00191375021155 ()

  • Depth: 27 Millimeter
  • Angle: 12 degree
  • Width: 40 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Height: 16 Millimeter
  • Lordotic Angle 12 Deg
2312-0316-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree X-Large 15mm
TITAN SPINE, LLC
2312-0315-S
Not in Commercial Distribution

  • 00191375021148 ()

  • Width: 40 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Angle: 12 degree
  • Depth: 27 Millimeter
  • Height: 15 Millimeter
  • Lordotic Angle 12 Deg
2312-0315-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree X-Large 14mm
TITAN SPINE, LLC
2312-0314-S
Not in Commercial Distribution

  • 00191375021131 ()

  • Width: 40 Millimeter
  • Angle: 12 degree
  • Depth: 27 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Lordotic Angle 12 Deg
  • Height: 14 Millimeter
2312-0314-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree X-Large 13mm
TITAN SPINE, LLC
2312-0313-S
Not in Commercial Distribution

  • 00191375021124 ()

  • width(MLxAP), 40 x 27, mm
  • Depth: 27 Millimeter
  • Width: 40 Millimeter
  • Angle: 12 degree
  • Height: 13 Millimeter
  • Lordotic Angle 12 Deg
2312-0313-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree X-Large 12mm
TITAN SPINE, LLC
2312-0312-S
Not in Commercial Distribution

  • 00191375021117 ()

  • width(MLxAP), 40 x 27, mm
  • Angle: 12 degree
  • Depth: 27 Millimeter
  • Width: 40 Millimeter
  • Height: 12 Millimeter
  • Lordotic Angle 12 Deg
2312-0312-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree X-Large 11mm
TITAN SPINE, LLC
2312-0311-S
Not in Commercial Distribution

  • 00191375021100 ()

  • Angle: 12 degree
  • width(MLxAP), 40 x 27, mm
  • Width: 40 Millimeter
  • Depth: 27 Millimeter
  • Lordotic Angle 12 Deg
  • Height: 11 Millimeter
2312-0311-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree X-Large 10mm
TITAN SPINE, LLC
2312-0310-S
Not in Commercial Distribution

  • 00191375021094 ()

  • Depth: 27 Millimeter
  • Width: 40 Millimeter
  • Angle: 12 degree
  • width(MLxAP), 40 x 27, mm
  • Lordotic Angle 12 Deg
  • Height: 10 Millimeter
2312-0310-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Large 17mm
TITAN SPINE, LLC
2312-0217-S
Not in Commercial Distribution

  • 00191375021087 ()

  • Width: 36 Millimeter
  • width(MLxAP), 36 x 24, mm
  • Depth: 24 Millimeter
  • Angle: 12 degree
  • Lordotic Angle 12 Deg
  • Height: 17 Millimeter
2312-0217-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Large 16mm
TITAN SPINE, LLC
2312-0216-S
Not in Commercial Distribution

  • 00191375021070 ()

  • Depth: 24 Millimeter
  • Width: 36 Millimeter
  • Angle: 12 degree
  • width(MLxAP), 36 x 24, mm
  • Height: 16 Millimeter
  • Lordotic Angle 12 Deg
2312-0216-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Large 15mm
TITAN SPINE, LLC
2312-0215-S
Not in Commercial Distribution

  • 00191375021063 ()

  • Width: 36 Millimeter
  • Angle: 12 degree
  • width(MLxAP), 36 x 24, mm
  • Depth: 24 Millimeter
  • Height: 15 Millimeter
  • Lordotic Angle 12 Deg
2312-0215-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Large 14mm
TITAN SPINE, LLC
2312-0214-S
Not in Commercial Distribution

  • 00191375021056 ()

  • Angle: 12 degree
  • Depth: 24 Millimeter
  • width(MLxAP), 36 x 24, mm
  • Width: 36 Millimeter
  • Height: 14 Millimeter
  • Lordotic Angle 12 Deg
2312-0214-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Large 13mm
TITAN SPINE, LLC
2312-0213-S
Not in Commercial Distribution

  • 00191375021049 ()

  • Angle: 12 degree
  • Width: 36 Millimeter
  • width(MLxAP), 36 x 24, mm
  • Depth: 24 Millimeter
  • Lordotic Angle 12 Deg
  • Height: 13 Millimeter
2312-0213-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Large 12mm
TITAN SPINE, LLC
2312-0212-S
Not in Commercial Distribution

  • 00191375021032 ()

  • Depth: 24 Millimeter
  • width(MLxAP), 36 x 24, mm
  • Angle: 12 degree
  • Width: 36 Millimeter
  • Lordotic Angle 12 Deg
  • Height: 12 Millimeter
2312-0212-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Large 11mm
TITAN SPINE, LLC
2312-0211-S
Not in Commercial Distribution

  • 00191375021025 ()

  • Angle: 12 degree
  • Depth: 24 Millimeter
  • Width: 36 Millimeter
  • width(MLxAP), 36 x 24, mm
  • Lordotic Angle 12 Deg
  • Height: 11 Millimeter
2312-0211-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Large 10mm
TITAN SPINE, LLC
2312-0210-S
Not in Commercial Distribution

  • 00191375021018 ()

  • width(MLxAP), 36 x 24, mm
  • Width: 36 Millimeter
  • Angle: 12 degree
  • Depth: 24 Millimeter
  • Height: 10 Millimeter
  • Lordotic Angle 12 Deg
2312-0210-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Standard 17mm
TITAN SPINE, LLC
2312-0117-S
Not in Commercial Distribution

  • 00191375021001 ()

  • width(MLxAP), 32 x 21, mm
  • Width: 32 Millimeter
  • Depth: 21 Millimeter
  • Angle: 12 degree
  • Height: 17 Millimeter
  • Lordotic Angle 12 Deg
2312-0117-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Standard 16mm
TITAN SPINE, LLC
2312-0116-S
Not in Commercial Distribution

  • 00191375020998 ()

  • width(MLxAP), 32 x 21, mm
  • Angle: 12 degree
  • Depth: 21 Millimeter
  • Width: 32 Millimeter
  • Height: 16 Millimeter
  • Lordotic Angle 12 Deg
2312-0116-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Standard 15mm
TITAN SPINE, LLC
2312-0115-S
Not in Commercial Distribution

  • 00191375020981 ()

  • Width: 32 Millimeter
  • width(MLxAP), 32 x 21, mm
  • Depth: 21 Millimeter
  • Angle: 12 degree
  • Height: 15 Millimeter
  • Lordotic Angle 12 Deg
2312-0115-S

  • Metallic spinal interbody fusion cage
Interbody Fusion Device 12 Degree Standard 14mm
TITAN SPINE, LLC
2312-0114-S
Not in Commercial Distribution

  • 00191375020974 ()

  • Width: 32 Millimeter
  • width(MLxAP), 32 x 21, mm
  • Depth: 21 Millimeter
  • Angle: 12 degree
  • Height: 14 Millimeter
  • Lordotic Angle 12 Deg
2312-0114-S

  • Metallic spinal interbody fusion cage
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