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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16 Deg Lordotic, Rasp, Standard, 10mm
MEDTRONIC SOFAMOR DANEK, INC.
2316-7110
In Commercial Distribution

  • 00191375027775 ()

  • width(MLxAP), 32 x 21, mm
  • Depth: 21 Millimeter
  • Width: 32 Millimeter
  • Angle: 16 degree
  • Lordotic Angle 16 Deg
  • Height: 10 Millimeter


  • Bone file/rasp, manual, reusable
.25 SQ. Quick Connect Ratcheting T-Handle
TITAN SPINE, LLC
2300-1315
In Commercial Distribution

  • 00191375025801 ()
2300-1315

  • Surgical instrument handle, non-torque-limiting
Quick Inserter
TITAN SPINE, LLC
2300-1312
In Commercial Distribution

  • 00191375025795 ()
2300-1312

  • Orthopaedic inorganic implant inserter/extractor, reusable
Fixed Angle Driver Ancillary Handle
TITAN SPINE, LLC
2300-1314
Not in Commercial Distribution

  • 00191375025733 ()
2300-1314

  • Orthopaedic inorganic implant inserter/extractor, reusable
40 Deg Fixed Angle Driver
TITAN SPINE, LLC
2300-1313
Not in Commercial Distribution

  • 00191375025726 ()
2300-1313

  • Orthopaedic inorganic implant inserter/extractor, reusable
TSA Elite Harness
1073849 Ontario Limited
T016-BSO
In Commercial Distribution

  • 00817956023263 ()

  • Height: 13 Inch
  • Width: 8 Inch
  • Depth: 4 Inch


  • Stand-up mobile patient lifting system sling/harness
Angled Driver, Handle
MEDTRONIC SOFAMOR DANEK, INC.
2300-1323
In Commercial Distribution

  • 00191375050469 ()

  • Width: 6 Inch


  • Orthopaedic implant driver
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
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
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
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
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