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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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Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Low Height 440cc
Establishment Labs S.A.
L-13-440
In Commercial Distribution

  • 07445161020864 ()
L-13-440

  • Skin-port tissue expander
Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Low Height 260cc
Establishment Labs S.A.
L-11-260
In Commercial Distribution

  • 07445161020840 ()
L-11-260

  • Skin-port tissue expander
The subjected screw is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
1
Not in Commercial Distribution

  • 07290019421238 ()
ZF-40FS-20TU

  • Spinal bone screw, non-bioabsorbable
The subjected Spacer of 4.0 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
3
In Commercial Distribution

  • 07290019421221 ()

  • Height: 4.0 Millimeter
ZF-30MX-40TU

  • Spinal bone screw, non-bioabsorbable
The subjected Spacer of 3.0 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
3
In Commercial Distribution

  • 07290019421207 ()

  • Height: 3.0 Millimeter
ZF-30MX-30TU

  • Spinal bone screw, non-bioabsorbable
The subjected Spacer of 2.5 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
3
In Commercial Distribution

  • 07290019421191 ()

  • Height: 2.5 Millimeter
ZF-30MX-25TU

  • Spinal bone screw, non-bioabsorbable
The subjected Spacer of 2.0 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.
ZYGOFIX LTD
3
In Commercial Distribution

  • 07290019421184 ()

  • Height: 2.0 Millimeter
ZF-30MX-20TU

  • Spinal bone screw, non-bioabsorbable
The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
ZYGOFIX LTD
1
In Commercial Distribution

  • 07290019421160 ()
ZFT-100

  • Spinal bone screw, non-bioabsorbable
The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
ZYGOFIX LTD
1
In Commercial Distribution

  • 07290019421146 ()


  • Spinal bone screw, non-bioabsorbable
The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
ZYGOFIX LTD
1
In Commercial Distribution

  • 07290019421122 ()
ZFT-100

  • Spinal bone screw, non-bioabsorbable
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