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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ACURA Stabilization System 8.5 mm x 50 mm Polyaxial Screw
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.0550
In Commercial Distribution

  • B922A00405500 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 50 Millimeter
A004.0550

  • Bone-screw internal spinal fixation system, non-sterile
ACURA Stabilization System 7.5 mm x 50 mm Polyaxial Screw
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.0450
In Commercial Distribution

  • B922A00404500 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 50 Millimeter
A004.0450

  • Bone-screw internal spinal fixation system, non-sterile
ACURA Stabilization System 6.5 mm x 50 mm Polyaxial Screw
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.0350
In Commercial Distribution

  • B922A00403500 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 50 Millimeter
A004.0350

  • Bone-screw internal spinal fixation system, non-sterile
ACURA Stabilization System 5.5 mm x 50 mm Polyaxial Screw
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.0250
In Commercial Distribution

  • B922A00402500 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter
A004.0250

  • Bone-screw internal spinal fixation system, non-sterile
7.5mm x 50mm Tall Cannulated Polyaxial Pedicle Screw
CPM MEDICAL CONSULTANTS, LLC
Rev D
In Commercial Distribution

  • B565FZTC7550CA0 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 50 Millimeter
FZ-TC7550CA

  • Bone-screw internal spinal fixation system, non-sterile
Alpha Reduction Pedicle Screw - Ø 6.5 mm x 50 mm
Republic Spine, LLC
100005-6550
In Commercial Distribution

  • B07510000565500 ()

  • Length: 50 Millimeter
  • 6.5mm diameter
DSDAR-6550

  • Bone-screw internal spinal fixation system, non-sterile
Alpha Reduction Pedicle Screw - Ø 5.5 mm x 50 mm
Republic Spine, LLC
100005-5550
In Commercial Distribution

  • B07510000555500 ()

  • 5.5mm diameter
  • Length: 50 Millimeter
DSDAR-5550

  • Bone-screw internal spinal fixation system, non-sterile
Alpha Pedicle Screw - Ø 8.5 mm x 50 mm
Republic Spine, LLC
100008-8550
Not in Commercial Distribution

  • B07510000885500 ()

  • Length: 50 Millimeter
  • 8.5mm diameter
DSDA-8550

  • Bone-screw internal spinal fixation system, non-sterile
Alpha Pedicle Screw - Ø 7.5 mm x 50 mm
Republic Spine, LLC
100008-7550
Not in Commercial Distribution

  • B07510000875500 ()

  • Length: 50 Millimeter
  • 7.5mm diameter
DSDA-7550

  • Bone-screw internal spinal fixation system, non-sterile
Alpha Low Top Pedicle Screw - Ø 6.5 mm x 50 mm
Republic Spine, LLC
100008-6550
In Commercial Distribution

  • B07510000865500 ()

  • 6.5mm diameter
  • Length: 50 Millimeter
DSDA-6550

  • Bone-screw internal spinal fixation system, non-sterile
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