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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 Type Device Class Implantable

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SeaSpine Spacer System - Ventura™ NanoMetalene® - 10889981049683

Ventura NM Implant, 9mm x 32mm x 10mm
SEASPINE ORTHOPEDICS CORPORATION
33-6210
In Commercial Distribution

  • 10889981049683 ()

  • 9mm x 32mm x 10mm
33-6210

  • Vertebral body prosthesis, non-sterile

SeaSpine Spacer System - Ventura™ NanoMetalene® - 10889981049669

Ventura NM Implant, 9mm x 32mm x 8mm
SEASPINE ORTHOPEDICS CORPORATION
33-6208
In Commercial Distribution

  • 10889981049669 ()

  • 9mm x 32mm x 8mm
33-6208

  • Vertebral body prosthesis, non-sterile

Integra Expandable Interbody - 10889981049645

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

Integra Expandable Interbody - 10889981049621

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

Integra Expandable Interbody - 10889981049607

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

Integra Expandable Interbody - 10889981049584

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

Integra Expandable Interbody - 10889981049577

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

Integra Expandable Interbody - 10889981049553

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

Integra Expandable Interbody - 10889981049546

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

Integra Expandable Interbody - 10889981049515

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
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