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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TI HBS self-drilling high compression screw,cannulated,28mm
mahe medical gmbh
HBS-1002-28S
In Commercial Distribution

  • EMAHHBS100228S1 ()
  • EMAHHBS100228S0 ()

  • Length: 28 Millimeter
  • Outer Diameter: 3.0 Millimeter
HBS-1002-28S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Screw 4.5 x 28mm s/s self-tapping
mahe medical gmbh
930545028
In Commercial Distribution

  • EMAH9305450281 ()
  • EMAH9305450280 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 28 Millimeter
930545028

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
TWO-LEVEL CERVICAL PLATE, 28 mm (39)
Xtant Medical Holdings, Inc.
X086-1128-STR
In Commercial Distribution

  • M697X0861128STR1 ()

  • Length: 28 Millimeter
  • Length: 39 Millimeter


  • Spinal fixation plate, non-bioabsorbable
ONE-LEVEL CERVICAL PLATE, 17 mm (28)
Xtant Medical Holdings, Inc.
X086-1017-STR
In Commercial Distribution

  • M697X0861017STR1 ()

  • Length: 28 Millimeter
  • Length: 17 Millimeter


  • Spinal fixation plate, non-bioabsorbable
IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 12°, 19mm, CE MARKED
Xtant Medical Holdings, Inc.
X080-382819-12X
In Commercial Distribution

  • M697X08038281912X1 ()

  • Length: 28 Millimeter
  • Height: 19 Millimeter
  • Angle: 12 degree
  • Width: 38 Millimeter


  • Polymeric spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 12°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382819-12T-STR
In Commercial Distribution

  • M697X08038281912TSTR1 ()

  • Height: 19 Millimeter
  • Angle: 12 degree
  • Width: 38 Millimeter
  • Length: 28 Millimeter


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 38 X 28 X 12°, 19mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-382819-12TPC-STR
In Commercial Distribution

  • M697X08038281912TPCSTR1 ()

  • Angle: 12 degree
  • Width: 38 Millimeter
  • Length: 28 Millimeter
  • Height: 19 Millimeter


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 38 X 28 X 12°, 19mm, PC
Xtant Medical Holdings, Inc.
X080-382819-12TPC
In Commercial Distribution

  • M697X08038281912TPC1 ()

  • Width: 38 Millimeter
  • Angle: 12 degree
  • Length: 28 Millimeter
  • Height: 19 Millimeter


  • Metallic spinal fusion cage, non-sterile
IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 12°, 19mm
Xtant Medical Holdings, Inc.
X080-382819-12T
In Commercial Distribution

  • M697X08038281912T1 ()

  • Width: 38 Millimeter
  • Angle: 12 degree
  • Length: 28 Millimeter
  • Height: 19 Millimeter


  • Metallic spinal fusion cage, non-sterile
IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 12°, 19mm (STERILE), CE MARKED
Xtant Medical Holdings, Inc.
X080-382819-12-STRX
In Commercial Distribution

  • M697X08038281912STRX1 ()

  • Height: 19 Millimeter
  • Length: 28 Millimeter
  • Width: 38 Millimeter
  • Angle: 12 degree


  • Polymeric spinal fusion cage, sterile
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