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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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CD Horizon™ ModuLeX™ Spinal System - 00763000866167

UAS/SS 559200099 5.5/6.0 CC VOYGR SINGLE
MEDTRONIC SOFAMOR DANEK, INC.
559200099
In Commercial Distribution

  • 00763000866167 ()


  • Spinal bone screw, non-bioabsorbable

CD Horizon™ ModuLeX™ Spinal System - 00763000848538

MAS/SS 559200096 5.5/6.0 CC VOYGR SINGLE
MEDTRONIC SOFAMOR DANEK, INC.
559200096
In Commercial Distribution

  • 00763000848538 ()


  • Spinal bone screw, non-bioabsorbable

ASCENT LE - 18257200064649

3.5MM X 52MM C-C BIASED ANGLE SCREW ASSY
Orthofix US LLC
66-3752
In Commercial Distribution

  • 18257200064649 ()


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

ASCENT LE - 18257200064632

3.5MM X 50MM C-C BIASED ANGLE SCREW ASSY
Orthofix US LLC
66-3750
In Commercial Distribution

  • 18257200064632 ()


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

ASCENT LE - 18257200064625

3.5MM X 48MM C-C BIASED ANGLE SCREW ASSY
Orthofix US LLC
66-3748
In Commercial Distribution

  • 18257200064625 ()


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

ASCENT LE - 18257200064618

3.5MM X 46MM C-C BIASED ANGLE SCREW ASSY
Orthofix US LLC
66-3746
In Commercial Distribution

  • 18257200064618 ()


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

ASCENT LE - 18257200064601

3.5MM X 44MM C-C BIASED ANGLE SCREW ASSY
Orthofix US LLC
66-3744
In Commercial Distribution

  • 18257200064601 ()


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

ASCENT LE - 18257200064595

3.5MM X 42MM C-C BIASED ANGLE SCREW ASSY
Orthofix US LLC
66-3742
In Commercial Distribution

  • 18257200064595 ()


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

J-VAC - 10705031003293

Bulb Suction Reservoir 100 cc with Anti-Reflux Valve
Ethicon Inc.
2160
In Commercial Distribution

  • 20705031003290 ()
  • 10705031003293 ()
2160

  • Closed-wound/centesis drainage receptacle

Tranquil-C™ - B6785233760

Cervical IBD 12x18x14 Planar, 0 Deg, 0.88 cc
NEXUS SPINE, L.L.C.
523376
In Commercial Distribution

  • B6785233760 ()

  • Width: 18 Millimeter
  • Length: 14 Millimeter
  • Height: 12 Millimeter


  • Metallic spinal interbody fusion cage
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