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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.
8060-0009S
In Commercial Distribution
- 08809974779347 ()
8060-0009S
- Polymeric spinal interbody fusion cage
Standard Implant Kit + 18x15 implants and trials + Directional Blade
PRECISION SPINE, INC.
37-BK-0104
In Commercial Distribution
- 00840019936316 ()
37-BK-0104
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Polymeric spinal interbody fusion cage
- Spinal fixation plate, non-bioabsorbable
- Spinal bone screw, non-bioabsorbable
Standard Implant Kit + Directional Blade
PRECISION SPINE, INC.
37-BK-0103
In Commercial Distribution
- 00840019936309 ()
37-BK-0103
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Polymeric spinal interbody fusion cage
- Spinal fixation plate, non-bioabsorbable
- Spinal bone screw, non-bioabsorbable
Standard Implant Kit + 18x15 implants and trials
PRECISION SPINE, INC.
37-BK-0102
In Commercial Distribution
- 00840019936293 ()
37-BK-0102
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Polymeric spinal interbody fusion cage
- Spinal fixation plate, non-bioabsorbable
- Spinal bone screw, non-bioabsorbable
Standard Implant Kit: Screws, 14x12, 16x14 implants and trials
PRECISION SPINE, INC.
37-BK-0101
In Commercial Distribution
- 00840019936286 ()
37-BK-0101
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Polymeric spinal interbody fusion cage
- Spinal fixation plate, non-bioabsorbable
- Spinal bone screw, non-bioabsorbable
Vault Plate and Cages System
PRECISION SPINE, INC.
21-1040-2
In Commercial Distribution
- 00840019936781 ()
21-1040-2
- Polymeric spinal interbody fusion cage
- Spinal fixation plate, non-bioabsorbable
- Orthopaedic surgical procedure kit, non-medicated, reusable
ShurFit™ MALIF Implant Case
PRECISION SPINE, INC.
23-9103
In Commercial Distribution
- 00840019936903 ()
23-9103
- Polymeric spinal interbody fusion cage
- Orthopaedic surgical procedure kit, non-medicated, reusable
Instrument and Implant Tray
PRECISION SPINE, INC.
21-1026
In Commercial Distribution
- 00840019936873 ()
21-1026
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Polymeric spinal interbody fusion cage
Instrument and Implant Tray
PRECISION SPINE, INC.
21-1032
In Commercial Distribution
- 00840019936835 ()
21-1032
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Polymeric spinal interbody fusion cage
Instrument and Implant Tray
PRECISION SPINE, INC.
21-1039
In Commercial Distribution
- 00840019936828 ()
21-1039
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Polymeric spinal interbody fusion cage