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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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Expansion Driver. 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). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2002
In Commercial Distribution

  • 10889981049416 ()
98-2002

  • Surgical drill guide, reusable
Inserter. 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). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2001
Not in Commercial Distribution

  • 10889981049409 ()
98-2001

  • Orthopaedic implant inserter/extractor, reusable
Inserter. 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). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2000
Not in Commercial Distribution

  • 10889981049393 ()
98-2000

  • Orthopaedic implant inserter/extractor, reusable
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, 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
82-3110
Not in Commercial Distribution

  • 10889981049379 ()

  • 30mm LG, 10-15mm HT, 12mm WD, 0°
82-3110

  • 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, 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
82-3012
Not in Commercial Distribution

  • 10889981049355 ()

  • 30mm LG, 12-18mm HT, 10mm WD, 0°
82-3012

  • 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, 30mm 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
82-3008
Not in Commercial Distribution

  • 10889981049331 ()

  • 30mm LG, 8-12mm HT, 10mm WD, 0°
82-3008

  • 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
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