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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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Renew-Cera is a coralline hydroxyapatite and a more active tricalcium phosphate bone grafting material for dental and craniofacial usage. It is comprised of 60% silicon substituted hydroxyapatite and 40% [3-tricalcium phosphate.
Meta Biomed Co., Ltd.
9677
In Commercial Distribution

  • 08806387896777 ()


  • Dental bone matrix implant, animal-derived
Renew-Cera is a coralline hydroxyapatite and a more active tricalcium phosphate bone grafting material for dental and craniofacial usage. It is comprised of 60% silicon substituted hydroxyapatite and 40% [3-tricalcium phosphate.
Meta Biomed Co., Ltd.
9676
In Commercial Distribution

  • 08806387896760 ()


  • Dental bone matrix implant, animal-derived
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
86002
In Commercial Distribution

  • 07290014064089 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
85860
In Commercial Distribution

  • 07290014064072 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
82645
In Commercial Distribution

  • 07290014064065 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
86001
In Commercial Distribution

  • 07290014064058 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
85859
In Commercial Distribution

  • 07290014064041 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
82644
In Commercial Distribution

  • 07290014064034 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
86000
In Commercial Distribution

  • 07290014064027 ()


  • Posterior lumbar spine prosthesis
The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression.
PREMIA SPINE LTD
85858
In Commercial Distribution

  • 07290014064010 ()


  • Posterior lumbar spine prosthesis
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