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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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MatrixMANDIBLE - 10887587004709

PSPC MATRIXMANDIBLE 20 HOLE RECON PLATE 2.5MM THICK
Synthes GmbH
SD449.509
In Commercial Distribution

  • H980SD4495090 ()
  • 10887587004709 ()
SD449509

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

GFS - M685100540

Large Graft Fixation System, 20 mm Suture Loop
PARCUS MEDICAL LLC
10054
In Commercial Distribution

  • M685100540 ()

  • 20 mm Suture Loop
10054

  • Tendon/ligament bone anchor, non-bioabsorbable

MiTi - M68510443T1

2.0mm MiTi Suture Anchor w/ One 2-0 Sutures
PARCUS MEDICAL LLC
10443T
In Commercial Distribution

  • M68510443T1 ()
  • M68510443T0 ()

  • Outer Diameter: 2.0 Millimeter
10443T

  • Tendon/ligament bone anchor, non-bioabsorbable

GFS - M685100490

Standard Graft Fixation System, 20 mm Suture Loop
PARCUS MEDICAL LLC
10049
In Commercial Distribution

  • M685100490 ()

  • 20 mm Suture Loop
10049

  • Tendon/ligament bone anchor, non-bioabsorbable

Irix-A Lumbar Integrated Fusion System - M697T08038281520TR1

38 X 28 X 15mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-382815-20TR
In Commercial Distribution

  • M697T08038281520TR0 ()
  • M697T08038281520TR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 15mm height, 20 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301920TR1

42 X 30 X 19mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423019-20TR
In Commercial Distribution

  • M697T08042301920TR0 ()
  • M697T08042301920TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 19mm height, 20 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301916TR1

38 X 28 X 13mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423019-16TR
In Commercial Distribution

  • M697T08042301916TR0 ()
  • M697T08042301916TR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 13mm height, 20 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301720TR1

42 X 30 X 17mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423017-20TR
In Commercial Distribution

  • M697T08042301720TR0 ()
  • M697T08042301720TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 17mm height, 20 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301520TR1

42 X 30 X 15mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423015-20TR
In Commercial Distribution

  • M697T08042301520TR0 ()
  • M697T08042301520TR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 15mm height, 20 DEG TRIAL


  • Spinal implant trial

Irix-A Lumbar Integrated Fusion System - M697T08042301320TR1

38 X 28 X 15mm, 20 DEG TRIAL
Xtant Medical Holdings, Inc.
T080-423013-20TR
In Commercial Distribution

  • M697T08042301320TR0 ()
  • M697T08042301320TR1 ()

  • 28mm depth X 15mm height, 20 DEG TRIAL
  • Width: 38 Millimeter


  • Spinal implant trial
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