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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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Hollywood NM Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
93-4506
In Commercial Distribution

  • 10889981049652 ()
93-4506

  • Vertebral body prosthesis, non-sterile
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
26mm 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
98-2922
Not in Commercial Distribution

  • 10889981049638 ()

  • 26mm
98-2922

  • Instrument tray, reusable
Implant 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
98-2920
Not in Commercial Distribution

  • 10889981049614 ()
98-2920

  • Instrument tray, reusable
Guide Hex Rod. 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
98-2205
Not in Commercial Distribution

  • 10889981049591 ()
98-2205

  • Surgical implant/trial-implant/sizer holder, reusable
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
18mm 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
98-2118
Not in Commercial Distribution

  • 10889981049560 ()

  • 18mm (22x10mm, 0°)
98-2118

  • Orthopaedic implant inserter/extractor, 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
14mm 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
98-2114
Not in Commercial Distribution

  • 10889981049522 ()

  • 14mm (22x10mm, 0°)
98-2114

  • 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
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