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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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The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114162 ()

  • 18x10x32mm
TST20181032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113752 ()

  • 18x10x28mm
TST20181028

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844113738 ()

  • 14x10x28mm
TST20141028

  • Metallic spinal interbody fusion cage
Filters out particles and microbiological contamination 0.22 micron and larger.
HURRICANE MEDICAL INC
9301
In Commercial Distribution

  • 10813465012122 ()
  • 00813465012125 ()
9301

  • Syringe filter, clinical
No Description
G21 SRL
900199
In Commercial Distribution

  • 08058964727596 ()


  • Balloon kyphoplasty kit
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB5820
In Commercial Distribution

  • 00813909012919 ()

  • 8x9.4x25mm
NB5820

  • Bone matrix implant, synthetic, non-antimicrobial
Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal flange of the prosthesis and the tracheal mucosa. It provides an extra seal against periprosthetic leakage through the adherence of the thin silicone sheet to the tracheal mucosa. The device is supplied sterile and is intended for single use only.
Atos Medical AB
7276
In Commercial Distribution

  • 07331791006937 ()

  • Voice Prosthesis Compatibility Fits 20 Fr voice prosthesis
7276

  • Tracheoesophageal speech valve, indwelling
No Description
WEST PHARMA. SERVICES IL, . LTD
8074029
In Commercial Distribution

  • 07290108240771 ()


  • Vial/bottle adaptor, hermetic
Pacemaker
BOSTON SCIENTIFIC CORPORATION
S205
In Commercial Distribution

  • 00802526499210 ()


  • Dual-chamber implantable pacemaker, rate-responsive
Pacemaker
BOSTON SCIENTIFIC CORPORATION
S208
In Commercial Distribution

  • 00802526484421 ()


  • Dual-chamber implantable pacemaker, rate-responsive
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