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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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13mm Trial (22x10mm, 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). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2113
Not in Commercial Distribution

  • 10889981049515 ()

  • 13mm (22x10mm, 0°)
98-2113

  • Orthopaedic implant inserter/extractor, reusable
12mm Trial (22x10mm, 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). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2112
Not in Commercial Distribution

  • 10889981049508 ()

  • 12mm (22x10mm, 0°)
98-2112

  • Orthopaedic implant inserter/extractor, reusable
11mm Trial (22x10mm, 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). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2111
Not in Commercial Distribution

  • 10889981049492 ()

  • 11mm (22x10mm, 0°)
98-2111

  • Orthopaedic implant inserter/extractor, reusable
10mm Trial (22x10mm, 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). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2110
In Commercial Distribution

  • 10889981049485 ()

  • 10mm (22x10mm, 0°)
98-2110

  • Orthopaedic implant inserter/extractor, reusable
9mm Trial (22x10mm, 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). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2109
Not in Commercial Distribution

  • 10889981049478 ()

  • 9mm (22x10mm, 0°)
98-2109

  • Orthopaedic implant inserter/extractor, reusable
8mm Trial (22x10mm, 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). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2108
Not in Commercial Distribution

  • 10889981049461 ()

  • 8mm (22x10mm, 0°)
98-2108

  • Orthopaedic implant inserter/extractor, reusable
6mm Starter Trial. 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
98-2105
Not in Commercial Distribution

  • 10889981049454 ()

  • 6mm
98-2105

  • Orthopaedic implant inserter/extractor, reusable
12mm Wide Removal Tool. 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
98-2012
Not in Commercial Distribution

  • 10889981049447 ()

  • 12mm
98-2012

  • Orthopaedic implant inserter/extractor, reusable
Removal Tool. 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
98-2011
Not in Commercial Distribution

  • 10889981049430 ()
98-2011

  • Orthopaedic implant inserter/extractor, reusable
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
98-2010
Not in Commercial Distribution

  • 10889981049423 ()

  • 10mm
98-2010

  • Orthopaedic implant inserter/extractor, reusable
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