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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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IMPLANT, 22mm LG, 8-12mm 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
82-2308
Not in Commercial Distribution

  • 10889981049249 ()

  • 22mm LG, 8-12mm HT, 12mm WD, 0°
82-2308

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 12-18mm HT, 10mm 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
82-2212
Not in Commercial Distribution

  • 10889981049232 ()

  • 22mm LG, 12-18mm HT, 10mm WD, 0°
82-2212

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 10-15mm HT, 10mm 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
82-2210
Not in Commercial Distribution

  • 10889981049225 ()

  • 22mm LG, 10-15mm HT, 10mm WD, 0°
82-2210

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 8-12mm HT, 10mm 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
82-2208
Not in Commercial Distribution

  • 10889981049218 ()

  • 22mm LG, 8-12mm HT, 10mm WD, 0°
82-2208

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 14.65mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2616
In Commercial Distribution

  • 10889981049201 ()

  • 30mm x 14.65mm
14-34-2616

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 13.33mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2614
Not in Commercial Distribution

  • 10889981049195 ()

  • 30mm x 13.33mm
14-34-2614

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 11.85mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2612
Not in Commercial Distribution

  • 10889981049188 ()

  • 30mm x 11.85mm
14-34-2612

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 10.5mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2610
Not in Commercial Distribution

  • 10889981049171 ()

  • 30mm x 10.5mm
14-34-2610

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 14.65mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2216
Not in Commercial Distribution

  • 10889981049164 ()

  • 30mm x 14.65mm
14-34-2216

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 13.33mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2214
Not in Commercial Distribution

  • 10889981049157 ()

  • 30mm x 13.33mm
14-34-2214

  • Vertebral body prosthesis, non-sterile
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