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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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DISTRACTOR HEAD, 11MM
TITAN SPINE, LLC
2307-9011
Not in Commercial Distribution

  • M682230790110 ()

  • Height: 11 Millimeter
2307-9011

  • Spinal implant trial
DISTRACTOR HEAD, 10MM
TITAN SPINE, LLC
2307-9010
Not in Commercial Distribution

  • M682230790100 ()

  • Height: 10 Millimeter
2307-9010

  • Spinal implant trial
DISTRACTOR HEAD, 9MM
TITAN SPINE, LLC
2307-9009
Not in Commercial Distribution

  • M682230790090 ()

  • Height: 9 Millimeter
2307-9009

  • Spinal implant trial
DISTRACTOR HEAD, 8MM
TITAN SPINE, LLC
2307-9008
Not in Commercial Distribution

  • M682230790080 ()

  • Height: 8 Millimeter
2307-9008

  • Spinal implant trial
Interbody Fusion Device 6.5mm Implant Bone Screw 25mm
TITAN SPINE, LLC
2300-6525
Not in Commercial Distribution

  • M682230075250 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 25 Millimeter
  • Standard Bone Screw
  • 6.5mm Diameter, 25mm Length
2300-6525

  • Spinal bone screw, non-bioabsorbable
Interbody Fusion Device 6.5mm Implant Bone Screw 30mm
TITAN SPINE, LLC
2300-6530
Not in Commercial Distribution

  • M682230065300 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 30 Millimeter
  • 6.5mm Diameter, 30mm Length
  • Standard Bone Screw
2300-6530

  • Spinal bone screw, non-bioabsorbable
Interbody Fusion Device 6.5mm Implant Bone Screw 20mm
TITAN SPINE, LLC
2300-6520
Not in Commercial Distribution

  • M682230065200 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 20 Millimeter
  • Standard Bone Screw
  • 6.5mm Diameter, 20mm Length
2300-6520

  • Spinal bone screw, non-bioabsorbable
Interbody Fusion Device 5.5mm Implant Bone Screw 30mm
TITAN SPINE, LLC
2300-5530
Not in Commercial Distribution

  • M682230055300 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Standard Bone Screw
  • 5.5mm Diameter, 30mm Length
2300-5530

  • Spinal bone screw, non-bioabsorbable
Interbody Fusion Device 5.5mm Implant Bone Screw 25mm
TITAN SPINE, LLC
2300-5525
Not in Commercial Distribution

  • M682230055250 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 25 Millimeter
  • Standard Bone Screw
  • 5.5mm Diameter, 25mm Length
2300-5525

  • Spinal bone screw, non-bioabsorbable
Interbody Fusion Device 5.5mm Implant Bone Screw 20mm
TITAN SPINE, LLC
2300-5520
Not in Commercial Distribution

  • M682230055200 ()

  • Length: 20 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Standard Bone Screw
  • 5.5mm Diameter, 20mm Length
2300-5520

  • Spinal bone screw, non-bioabsorbable
HEX, SWIVEL, SCREWDRIVER
TITAN SPINE, LLC
2300-1302
Not in Commercial Distribution

  • M682230013020 ()

  • Length: 11 Inch
2300-1302

  • Orthopaedic inorganic implant inserter/extractor, reusable
HEX, STRAIGHT, SCREWDRIVER
TITAN SPINE, LLC
2300-1301
Not in Commercial Distribution

  • M682230013010 ()

  • Length: 9.5 Inch
2300-1301

  • Orthopaedic inorganic implant inserter/extractor, reusable
CURVED, FIXED HANDLE, SOLID AWL
TITAN SPINE, LLC
2300-1120
Not in Commercial Distribution

  • M682230011200 ()

  • Length: 15 Inch
2300-1120

  • Bone awl, reusable
FIXED HANDLE, STRAIGHT, SOLID AWL
TITAN SPINE, LLC
2300-1110
Not in Commercial Distribution

  • M682230011100 ()

  • Length: 15 Inch
2300-1110

  • Bone awl, reusable
REVERSE THREAD EXTRACTOR
TITAN SPINE, LLC
2300-1102
Not in Commercial Distribution

  • M682230011020 ()

  • Length: 12.5 Inch
2300-1102

  • Orthopaedic inorganic implant inserter/extractor, reusable
Curved, Solid Awl
TITAN SPINE, LLC
2300-1101
Not in Commercial Distribution

  • M682230011010 ()

  • Length: 9.5 Inch
2300-1101

  • Bone awl, reusable
Straight, Solid Awl
TITAN SPINE, LLC
2300-1100
Not in Commercial Distribution

  • M682230011000 ()

  • Length: 9.5 Inch
2300-1100

  • Bone awl, reusable
1/4IN SQUARE DRIVE, RATCHET, SCREWDRIVER, HANDLE
TITAN SPINE, LLC
2300-1046
Not in Commercial Distribution

  • M682230010460 ()

  • Length: 6 Inch
2300-1046

  • Surgical instrument handle, non-torque-limiting
1/4IN SQUARE DRIVE, NON-RATCHET, SCREWDRIVER, T-HANDLE
TITAN SPINE, LLC
2300-1039
Not in Commercial Distribution

  • M682230010390 ()

  • Width: 4 Inch
  • Width: 3 Inch
2300-1039

  • Surgical instrument handle, non-torque-limiting
1/4IN SQUARE DRIVE, NON-RATCHET, SCREWDRIVER, HANDLE
TITAN SPINE, LLC
2300-1038
Not in Commercial Distribution

  • M682230010380 ()

  • Width: 6 Inch
2300-1038

  • Surgical instrument handle, non-torque-limiting
AWL GUIDE
TITAN SPINE, LLC
2300-1036
Not in Commercial Distribution

  • M682230010360 ()

  • Length: 11 Inch
2300-1036

  • Orthopaedic implantation sleeve, reusable
U-JOINT AWL
TITAN SPINE, LLC
2300-1035
Not in Commercial Distribution

  • M682230010350 ()

  • Length: 12 Inch
2300-1035

  • Bone awl, reusable
HEX, U-JOINT SCREWDRIVER
TITAN SPINE, LLC
2300-1034
Not in Commercial Distribution

  • M682230010340 ()

  • Length: 11 Inch
2300-1034

  • Orthopaedic inorganic implant inserter/extractor, reusable
LOCKING, IMPLANT REMOVER
TITAN SPINE, LLC
2300-1015
Not in Commercial Distribution

  • M682230010150 ()

  • Length: 15 Inch
2300-1015

  • Orthopaedic inorganic implant inserter/extractor, reusable
IMPLANT REMOVER
TITAN SPINE, LLC
2300-1012
Not in Commercial Distribution

  • M682230010120 ()

  • Length: 12 Inch
2300-1012

  • Orthopaedic inorganic implant inserter/extractor, reusable
12 DEG LORDOTIC, TRIAL, X-LARGE, 17MM
TITAN SPINE, LLC
2112-9317
Not in Commercial Distribution

  • M682211293170 ()

  • Lordotic Angle 12 Deg
  • Height: 17 Millimeter
  • Angle: 12 degree
  • width(MLxAP), 40 x 27, mm
  • Width: 40 Millimeter
  • Depth: 27 Millimeter
2112-9317

  • Spinal implant trial
12 DEG LORDOTIC, TRIAL, X-LARGE, 16MM
TITAN SPINE, LLC
2112-9316
Not in Commercial Distribution

  • M682211293160 ()

  • Height: 16 Millimeter
  • Lordotic Angle 12 Deg
  • Width: 40 Millimeter
  • Angle: 12 degree
  • width(MLxAP), 40 x 27, mm
  • Depth: 27 Millimeter
2112-9316

  • Spinal implant trial
12 DEG LORDOTIC, TRIAL, X-LARGE, 15MM
TITAN SPINE, LLC
2112-9315
Not in Commercial Distribution

  • M682211293150 ()

  • Lordotic Angle 12 Deg
  • Height: 15 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Angle: 12 degree
  • Depth: 27 Millimeter
  • Width: 40 Millimeter
2112-9315

  • Spinal implant trial
12 DEG LORDOTIC, TRIAL, X-LARGE, 14MM
TITAN SPINE, LLC
2112-9314
Not in Commercial Distribution

  • M682211293140 ()

  • Lordotic Angle 12 Deg
  • Height: 14 Millimeter
  • Width: 40 Millimeter
  • Depth: 27 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Angle: 12 degree
2112-9314

  • Spinal implant trial
12 DEG LORDOTIC, TRIAL, X-LARGE, 13MM
TITAN SPINE, LLC
2112-9313
Not in Commercial Distribution

  • M682211293130 ()

  • Lordotic Angle 12 Deg
  • Height: 13 Millimeter
  • Depth: 27 Millimeter
  • Angle: 12 degree
  • width(MLxAP), 40 x 27, mm
  • Width: 40 Millimeter
2112-9313

  • Spinal implant trial
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