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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Assembly, Fortex, 4.75 x 35, Dual Lead, Cannulated Screw
Xtant Medical Holdings, Inc.
X022-0081-DL
In Commercial Distribution

  • M697X0220081DL1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 8.25 x 35 Cannulated Mini Reduction Screw
Xtant Medical Holdings, Inc.
X064-82535C
In Commercial Distribution

  • M697X06482535C1 ()

  • Outer Diameter: 8.25 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex Mini Reduction, 6.5 x 35 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X064-6535SD
In Commercial Distribution

  • M697X0646535SD1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 6.5 x 35 Cannulated Mini Reduction Screw
Xtant Medical Holdings, Inc.
X064-6535C
In Commercial Distribution

  • M697X0646535C1 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 4.75 x 35 Cannulated Mini Reduction Screw
Xtant Medical Holdings, Inc.
X064-47535C
In Commercial Distribution

  • M697X06447535C1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 8.25 x 35 Reduction, Dual Lead, Screw
Xtant Medical Holdings, Inc.
X064-0026-DL
In Commercial Distribution

  • M697X0640026DL1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 8.25 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 5.5 x 35 Reduction, Dual Lead, Screw
Xtant Medical Holdings, Inc.
X064-0008-DL
In Commercial Distribution

  • M697X0640008DL1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Polyaxial E Type MIS Pedicle Screw 5.5 x 35
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319789550 ()
FX.CL.5535

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial E Type MIS Pedicle Screw 6.5 x 35
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319789543 ()
FX.CL.6535

  • Bone-screw internal spinal fixation system, non-sterile
MIS Screw, Close Type(Self-tapping), Pi.5, 35, 127mm
L&K BIOMED CO. ,LTD.
2732-5535S
In Commercial Distribution

  • 08809319759270 ()
2732-5535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø7.5, 35, 127mm
L&K BIOMED CO. ,LTD.
2812-7535S
In Commercial Distribution

  • 08809319753742 ()
2812-7535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø6.5, 35, 127mm
L&K BIOMED CO. ,LTD.
2812-6535S
In Commercial Distribution

  • 08809319753674 ()
2812-6535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø5.5, 35, 127mm
L&K BIOMED CO. ,LTD.
2812-5535S
In Commercial Distribution

  • 08809319753605 ()
2812-5535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø7.5, 35, 117mm
L&K BIOMED CO. ,LTD.
2811-7535S
In Commercial Distribution

  • 08809319753537 ()
2811-7535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø6.5, 35, 117mm
L&K BIOMED CO. ,LTD.
2811-6535S
In Commercial Distribution

  • 08809319753469 ()
2811-6535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø5.5, 35, 117mm
L&K BIOMED CO. ,LTD.
2811-5535S
In Commercial Distribution

  • 08809319753391 ()
2811-5535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø7.5, 35, 107mm
L&K BIOMED CO. ,LTD.
2810-7535S
In Commercial Distribution

  • 08809319753322 ()
2810-7535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø6.5, 35, 107mm
L&K BIOMED CO. ,LTD.
2810-6535S
In Commercial Distribution

  • 08809319753254 ()
2810-6535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø5.5, 35, 107mm
L&K BIOMED CO. ,LTD.
2810-5535S
In Commercial Distribution

  • 08809319753186 ()
2810-5535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø7.5, 35, 97mm
L&K BIOMED CO. ,LTD.
2809-7535S
In Commercial Distribution

  • 08809319753117 ()
2809-7535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø6.5, 35, 97mm
L&K BIOMED CO. ,LTD.
2809-6535S
In Commercial Distribution

  • 08809319753049 ()
2809-6535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø5.5, 35, 97mm
L&K BIOMED CO. ,LTD.
2809-5535S
In Commercial Distribution

  • 08809319752974 ()
2809-5535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø7.5, 35, 87mm
L&K BIOMED CO. ,LTD.
2808-7535S
In Commercial Distribution

  • 08809319752905 ()
2808-7535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø6.5, 35, 87mm
L&K BIOMED CO. ,LTD.
2808-6535S
In Commercial Distribution

  • 08809319752837 ()
2808-6535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø5.5, 35, 87mm
L&K BIOMED CO. ,LTD.
2808-5535S
In Commercial Distribution

  • 08809319752769 ()
2808-5535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø7.5, 35, 77mm
L&K BIOMED CO. ,LTD.
2807-7535S
In Commercial Distribution

  • 08809319752691 ()
2807-7535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø6.5, 35, 77mm
L&K BIOMED CO. ,LTD.
2807-6535S
In Commercial Distribution

  • 08809319752622 ()
2807-6535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø5.5, 35, 77mm
L&K BIOMED CO. ,LTD.
2807-5535S
In Commercial Distribution

  • 08809319752554 ()
2807-5535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø7.5, 35, 67mm
L&K BIOMED CO. ,LTD.
2806-7535S
In Commercial Distribution

  • 08809319752486 ()
2806-7535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø6.5, 35, 67mm
L&K BIOMED CO. ,LTD.
2806-6535S
In Commercial Distribution

  • 08809319752417 ()
2806-6535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø5.5, 35, 67mm
L&K BIOMED CO. ,LTD.
2806-5535S
In Commercial Distribution

  • 08809319752349 ()
2806-5535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø7.5, 35, 57mm
L&K BIOMED CO. ,LTD.
2805-7540S
In Commercial Distribution

  • 08809319752288 ()
2805-7540S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø7.5, 35, 57mm
L&K BIOMED CO. ,LTD.
2805-7535S
In Commercial Distribution

  • 08809319752271 ()
2805-7535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø6.5, 35, 57mm
L&K BIOMED CO. ,LTD.
2805-6535S
In Commercial Distribution

  • 08809319752202 ()
2805-6535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø5.5, 35, 57mm
L&K BIOMED CO. ,LTD.
2805-5535S
In Commercial Distribution

  • 08809319752134 ()
2805-5535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø7.5, 35, 47mm
L&K BIOMED CO. ,LTD.
2804-7535S
In Commercial Distribution

  • 08809319752066 ()
2804-7535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø6.5, 35, 47mm
L&K BIOMED CO. ,LTD.
2804-6535S
In Commercial Distribution

  • 08809319751991 ()
2804-6535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Open Type(Non self-tapping), Ø5.5, 35, 47mm
L&K BIOMED CO. ,LTD.
2804-5535S
In Commercial Distribution

  • 08809319751922 ()
2804-5535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Close Type(Non self-tapping), Ø7.5, 35, 127mm
L&K BIOMED CO. ,LTD.
2912-7535S
In Commercial Distribution

  • 08809319751854 ()
2912-7535S

  • Spinal bone screw, non-bioabsorbable
MIS Screw, Close Type(Non self-tapping), Ø6.5, 35, 127mm
L&K BIOMED CO. ,LTD.
2912-6535S
In Commercial Distribution

  • 08809319751786 ()
2912-6535S

  • Spinal bone screw, non-bioabsorbable
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