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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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ACURA Stabilization System Ø 6.5 x 55 mm Polyaxial Screw - NT - B922A00473550

ACURA Stabilization System Ø 6.5 x 55 mm Polyaxial Screw - NT
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.7355
In Commercial Distribution

  • B922A00473550 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 55 Millimeter
A004.7355

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

ACURA Stabilization System Ø 5.5 x 55 mm Cannulated Polyaxial Screw - NT - B922A00472550

ACURA Stabilization System Ø 5.5 x 55 mm Cannulated Polyaxial Screw - NT
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.7255
In Commercial Distribution

  • B922A00472550 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter
A004.7255

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

ACURA Stabilization System - B922A00430550

ACURA Stabilization System 5.5 mm x 55 mm TAV Straight Rod
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.3055
In Commercial Distribution

  • B922A00430550 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter
A004.3055

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

ACURA Stabilization System - B922A00420550

ACURA Stabilization System 5.5 mm x 55 mm TAV Curved Rod
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.2055
In Commercial Distribution

  • B922A00420550 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter
A004.2055

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

ACURA Stabilization System 8.5mm x 55mm Polyaxial Screw - B922A00405550

ACURA Stabilization System 8.5mm x 55mm Polyaxial Screw
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.0555
In Commercial Distribution

  • B922A00405550 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 55 Millimeter
A004.0555

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

ACURA Stabilization System - B922A00404550

ACURA Stabilization System 7.5 mm x 55 mm Polyaxial Screw
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.0455
In Commercial Distribution

  • B922A00404550 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 55 Millimeter
A004.0455

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

ACURA Stabilization System - B922A00403550

ACURA Stabilization System 6.5 mm x 55 mm Polyaxial Screw
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.0355
In Commercial Distribution

  • B922A00403550 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 55 Millimeter
A004.0355

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

ACURA Stabilization System - B922A00402550

ACURA Stabilization System 5.5 mm x 55 mm Polyaxial Screw
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
A004.0255
In Commercial Distribution

  • B922A00402550 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter
A004.0255

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

Yellowstone - B587C13185540

13mm H x 18mm W x 55mm L x 4 degree XLIF Coronal Taper
SUMMIT SPINE LLC
1
In Commercial Distribution

  • B587C13185540 ()

  • Width: 18 Millimeter
  • Length: 55 Millimeter
  • Height: 13 Millimeter
  • Angle: 4 degree
C131855-4

  • Polymeric spinal interbody fusion cage

EPIPHANY - B582PSE55120

EPIPHANY 5/1 PEEK
PANTHEON SPINAL, LLC
1
In Commercial Distribution

  • B582PSE55120 ()

  • Length: 55 Millimeter
  • Height: 12 Millimeter
PSE 55-12

  • Polymeric spinal interbody fusion cage
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