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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, 30mm LG, 12-18mm 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
82-3112
Not in Commercial Distribution

  • 10889981049386 ()

  • 30mm LG, 12-18mm HT, 12mm WD, 0°
82-3112

  • Vertebral body prosthesis, non-sterile
IMPLANT, 30mm 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
82-3108
Not in Commercial Distribution

  • 10889981049362 ()

  • 30mm LG, 8-12mm HT, 12mm WD, 0°
82-3108

  • Vertebral body prosthesis, non-sterile
IMPLANT, 30mm 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
82-3010
Not in Commercial Distribution

  • 10889981049348 ()

  • 30mm LG, 10-15mm HT, 10mm WD, 0°
82-3010

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm LG, 12-18mm 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
82-2712
Not in Commercial Distribution

  • 10889981049324 ()

  • 26mm LG, 12-18mm HT, 12mm WD, 0°
82-2712

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm 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
82-2708
Not in Commercial Distribution

  • 10889981049300 ()

  • 26mm LG, 8-12mm HT, 12mm WD, 0°
82-2708

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm 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
82-2610
Not in Commercial Distribution

  • 10889981049287 ()

  • 26mm LG, 10-15mm HT, 10mm WD, 0°
82-2610

  • Vertebral body prosthesis, non-sterile
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
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, 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
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