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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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Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-16
In Commercial Distribution

83-00-16

  • Spinal fixation plate, non-bioabsorbable
Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-14
In Commercial Distribution

83-00-14

  • Spinal fixation plate, non-bioabsorbable
Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-12
In Commercial Distribution

83-00-12

  • Spinal fixation plate, non-bioabsorbable
Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-10
In Commercial Distribution

83-00-10

  • Spinal fixation plate, non-bioabsorbable
Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-08
In Commercial Distribution

83-00-08

  • Spinal fixation plate, non-bioabsorbable
DYMAXEON OPEN POLYAXIAL PEDICLE SCREW Ø5.5 x30mm (BLUE)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500023660 ()
  • 10815500023667 ()

  • Length: 30 Millimeter
06.6361B

  • Bone-screw internal spinal fixation system, sterile
DYMAXEON OPEN POLYAXIAL PEDICLE SCREW Ø5.5 x25mm (BLUE)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500023653 ()
  • 10815500023650 ()

  • Length: 25 Millimeter
06.6360B

  • Bone-screw internal spinal fixation system, sterile
DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X70mm (GREEN)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023264 ()
  • 10815500023261 ()

  • Length: 70 Millimeter
06.6638B

  • Bone-screw internal spinal fixation system, sterile
DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X55mm (GREEN)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023240 ()
  • 10815500023247 ()

  • Length: 55 Millimeter
06.6636B

  • Bone-screw internal spinal fixation system, sterile
DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X50mm (GREEN)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023233 ()
  • 10815500023230 ()

  • Length: 50 Millimeter
06.6635B

  • Bone-screw internal spinal fixation system, sterile
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