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 Type Device Class Implantable

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IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560).
SEASPINE ORTHOPEDICS CORPORATION
82-2312
Not in Commercial Distribution

  • 10889981049263 ()

  • 22mm LG, 12-18mm HT, 12mm WD, 0°
82-2312

  • Vertebral body prosthesis, non-sterile
LATERAL IMPLANT, NARROW, LORDOTIC, 8mm X 18mm X 55mm X 10°
SEASPINE ORTHOPEDICS CORPORATION
31-39-0855-10
In Commercial Distribution

  • 10889981048051 ()

  • 8mm X 18mm X 55mm X 10°
31-39-0855-10

  • Vertebral body prosthesis, non-sterile
LATERAL IMPLANT, NARROW, LORDOTIC, 8mm X 18mm X 45mm X 10°
SEASPINE ORTHOPEDICS CORPORATION
31-39-0845-10
In Commercial Distribution

  • 10889981048037 ()

  • 8mm X 18mm X 45mm X 10°
31-39-0845-10

  • Vertebral body prosthesis, non-sterile
LATERAL IMPLANT, NARROW, LORDOTIC, 8mm X 18mm X 40mm X 10°
SEASPINE ORTHOPEDICS CORPORATION
31-39-0840-10
In Commercial Distribution

  • 10889981048020 ()

  • 8mm X 18mm X 40mm X 10°
31-39-0840-10

  • Vertebral body prosthesis, non-sterile
LATERAL IMPLANT, WIDE, LORDOTIC, 8mm X 23mm X 55mm X 10°
SEASPINE ORTHOPEDICS CORPORATION
31-37-0855-10
In Commercial Distribution

  • 10889981047962 ()

  • 8mm X 23mm X 55mm X 10°
31-37-0855-10

  • Vertebral body prosthesis, non-sterile
LATERAL IMPLANT, LORDOTIC, 8mm X 23mm X 50mm X 10°
SEASPINE ORTHOPEDICS CORPORATION
31-37-0850-10
In Commercial Distribution

  • 10889981047955 ()

  • 8mm X 23mm X 50mm X 10°
31-37-0850-10

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 11mm x 28mm x 7mm
SEASPINE ORTHOPEDICS CORPORATION
33-6907
In Commercial Distribution

  • 10889981050016 ()

  • 11mm x 28mm x 7mm
33-6907

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 28mm x 18mm
SEASPINE ORTHOPEDICS CORPORATION
33-6818
In Commercial Distribution

  • 10889981050009 ()

  • 9mm x 28mm x 18mm
33-6818

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 28mm x 17mm
SEASPINE ORTHOPEDICS CORPORATION
33-6817
In Commercial Distribution

  • 10889981049997 ()

  • 9mm x 28mm x 17mm
33-6817

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 28mm x 16mm
SEASPINE ORTHOPEDICS CORPORATION
33-6816
In Commercial Distribution

  • 10889981049980 ()

  • 9mm x 28mm x 16mm
33-6816

  • Vertebral body prosthesis, non-sterile
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