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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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16 x 13 Lordotic Caddy Set, Irix-C
Xtant Medical Holdings, Inc.
X066-0233-CS
In Commercial Distribution

  • M697X0660233CS0 ()
  • M697X0660233CS1 ()


  • Polymeric spinal interbody fusion cage
16 x 13 Lordotic Caddy, Irix-C
Xtant Medical Holdings, Inc.
X066-0233
In Commercial Distribution

  • M697X06602330 ()
  • M697X06602331 ()


  • Polymeric spinal interbody fusion cage
STERILIZATION CASE, ADDITIONAL INSTRUMENTS, IRIX-C
Xtant Medical Holdings, Inc.
X066-0006
In Commercial Distribution

  • M697X06600060 ()
  • M697X06600061 ()


  • Polymeric spinal interbody fusion cage
Instrument Sterilization Case, Irix-C
Xtant Medical Holdings, Inc.
X066-0004
In Commercial Distribution

  • M697X06600040 ()
  • M697X06600041 ()


  • Polymeric spinal interbody fusion cage
Implant Sterilization Case, Irix-C
Xtant Medical Holdings, Inc.
X066-0003
In Commercial Distribution

  • M697X06600030 ()
  • M697X06600031 ()


  • Polymeric spinal interbody fusion cage
"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LT1) (Manufacturer – INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (""DDD"") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine."
GS Medical Co., Ltd.
8072-0010S
In Commercial Distribution

  • 08809885704070 ()
8072-0010S

  • Polymeric spinal interbody fusion cage
"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LT1) (Manufacturer – INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (""DDD"") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine."
GS Medical Co., Ltd.
8072-0009S
In Commercial Distribution

  • 08809885704063 ()
8072-0009S

  • Polymeric spinal interbody fusion cage
"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LT1) (Manufacturer – INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (""DDD"") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine."
GS Medical Co., Ltd.
8072-0008S
In Commercial Distribution

  • 08809885704056 ()
8072-0008S

  • Polymeric spinal interbody fusion cage
"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LT1) (Manufacturer – INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (""DDD"") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine."
GS Medical Co., Ltd.
8072-0007S
In Commercial Distribution

  • 08809885704049 ()
8072-0007S

  • Polymeric spinal interbody fusion cage
"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LT1) (Manufacturer – INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (""DDD"") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine."
GS Medical Co., Ltd.
8072-0006S
In Commercial Distribution

  • 08809885704032 ()
8072-0006S

  • Polymeric spinal interbody fusion cage
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