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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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Nautilus Assembly CA, Ø6.5 x 45 Long x 5 Lead
Life Spine, Inc.
365-45-5
In Commercial Distribution

  • 00190837056988 ()
365-45-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø6.5 x 35 Long x 5 Lead
Life Spine, Inc.
365-35-5
In Commercial Distribution

  • 00190837056940 ()
365-35-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø6.5 x 30 Long x 5 Lead
Life Spine, Inc.
365-30-5
In Commercial Distribution

  • 00190837056926 ()
365-30-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø5.5 x 50 Long x 5 Lead
Life Spine, Inc.
355-50-5
In Commercial Distribution

  • 00190837056872 ()
355-50-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø5.5 x 45 Long x 5 Lead
Life Spine, Inc.
355-45-5
In Commercial Distribution

  • 00190837056858 ()
355-45-5

  • Bone-screw internal spinal fixation system, non-sterile
120 Deg x 4.5mm Varus Plate, 14mm Offset, 5 Hole
ORTHOPEDIATRICS CORP.
00-0907-1465
In Commercial Distribution

  • 00841132104347 ()
00-0907-1465

  • Growth-correction orthopaedic fixation plate kit
120 Deg x 4.5mm Varus Plate, 6mm Offset, 5 Hole
ORTHOPEDIATRICS CORP.
00-0907-1365
In Commercial Distribution

  • 00841132104279 ()
00-0907-1365

  • Growth-correction orthopaedic fixation plate kit
HA PEEK EVOS Straight, ,10mmx10mmx 22mm , FLAT 5 ° , Narrow Nose
Cutting Edge Spine, LLC
4216-010
In Commercial Distribution

  • 00841193114705 ()

  • Length: 30 Millimeter
4216-010

  • Polymeric spinal fusion cage, sterile
HA PEEK EVOS Straight, ,9mmx10mmx 22mm , FLAT 5 ° , Narrow Nose
Cutting Edge Spine, LLC
4216-009
In Commercial Distribution

  • 00841193114699 ()

  • Length: 30 Millimeter
4216-009

  • Polymeric spinal fusion cage, sterile
HA PEEK EVOS Straight, ,15mmx9mmx 26mm , FLAT 5 ° , Narrow Nose
Cutting Edge Spine, LLC
4215-015
In Commercial Distribution

  • 00841193114651 ()

  • Length: 30 Millimeter
4215-015

  • Polymeric spinal fusion cage, sterile
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