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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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30mm Implant Caddyy. 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
98-2923
Not in Commercial Distribution

  • 10889981049645 ()

  • 30mm
98-2923

  • Instrument tray, reusable
22mm Implant Caddy. 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
98-2921
Not in Commercial Distribution

  • 10889981049621 ()

  • 22mm
98-2921

  • Instrument tray, reusable
Instrument Tray. 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
98-2900
Not in Commercial Distribution

  • 10889981049607 ()
98-2900

  • Instrument tray, reusable
Bone Funnel. 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
98-2202
Not in Commercial Distribution

  • 10889981049584 ()
98-2202

  • Bone graft funnel
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
98-2201
In Commercial Distribution

  • 10889981049577 ()
98-2201

  • Surgical drill guide, reusable
17mm 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
98-2117
Not in Commercial Distribution

  • 10889981049553 ()

  • 17mm (22x10mm, 0°)
98-2117

  • Orthopaedic implant inserter/extractor, reusable
16mm 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
98-2116
Not in Commercial Distribution

  • 10889981049546 ()

  • 16mm (22x10mm, 0°)
98-2116

  • Orthopaedic implant inserter/extractor, reusable
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
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, 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
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