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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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Interbody Inserter, Shaft
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B52110631630 ()
106-316-3

  • Polymeric spinal fusion cage, sterile
Interbody Inserter, Sleeve
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B52110631610 ()
106-316-1

  • Polymeric spinal fusion cage, sterile
Interbody Inserter, Anterior
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B5211063160 ()
106-316

  • Polymeric spinal fusion cage, sterile
AFFINITY, Trial Inserter
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B5211063020 ()
106-302

  • Polymeric spinal fusion cage, sterile
AFFINITY, Packing Block
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B5211063010 ()
106-301

  • Polymeric spinal fusion cage, sterile
AFFINITY, Implant Inserter
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B5211063000 ()
106-300

  • Polymeric spinal fusion cage, sterile
AFFINITY Lumbar Interbody Fusion System, 28mm x 38mm x 8 degrees x 17mm, UNCOATED
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B521106028380817UC0 ()

  • Height: 17 Millimeter
  • Angle: 8 degree
  • Width: 38 Millimeter
  • Length: 28 Millimeter
106-02838-0817-UC

  • Polymeric spinal fusion cage, sterile
AFFINITY Lumbar Interbody Fusion System, 28mm x 38mm x 8 degrees x 16mm, UNCOATED
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B521106028380816UC0 ()

  • Height: 16 Millimeter
  • Angle: 8 degree
  • Width: 38 Millimeter
  • Length: 28 Millimeter
106-02838-0816-UC

  • Polymeric spinal fusion cage, sterile
AFFINITY Lumbar Interbody Fusion System, 28mm x 38mm x 8 degrees x 15mm, UNCOATED
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B521106028380815UC0 ()

  • Height: 15 Millimeter
  • Angle: 8 degree
  • Width: 38 Millimeter
  • Length: 28 Millimeter
106-02838-0815-UC

  • Polymeric spinal fusion cage, sterile
AFFINITY Lumbar Interbody Fusion System, 28mm x 38mm x 8 degrees x 14mm, UNCOATED
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B521106028380814UC0 ()

  • Height: 14 Millimeter
  • Angle: 8 degree
  • Width: 38 Millimeter
  • Length: 28 Millimeter
106-02838-0814-UC

  • Polymeric spinal fusion cage, sterile
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