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"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.
1101-0008
In Commercial Distribution
- 08806378361666 ()
1101-0008
- 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.
1101-1011
In Commercial Distribution
- 08806378300894 ()
1101-1011
- 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.
1101-1009
In Commercial Distribution
- 08806378300870 ()
1101-1009
- 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.
1101-1008
In Commercial Distribution
- 08806378300863 ()
1101-1008
- 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.
1101-1013
In Commercial Distribution
- 08806378310343 ()
1101-1013
- 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.
1101-1012
In Commercial Distribution
- 08806378300900 ()
1101-1012
- 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.
1101-1010
In Commercial Distribution
- 08806378300887 ()
1101-1010
- Polymeric spinal interbody fusion cage
The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc.
The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868). The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient’s pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.
GS Medical Co., Ltd.
8071-1608S
In Commercial Distribution
- 08809974829158 ()
8071-1608S
- Polymeric spinal interbody fusion cage
The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc.
The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868). The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient’s pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.
GS Medical Co., Ltd.
8071-1607S
In Commercial Distribution
- 08809974829141 ()
8071-1607S
- Polymeric spinal interbody fusion cage
The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc.
The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868). The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient’s pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.
GS Medical Co., Ltd.
8071-1210S
In Commercial Distribution
- 08809974829134 ()
8071-1210S
- Polymeric spinal interbody fusion cage