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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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Zuma-C Implant, 13x12x9mm
Seaspine Orthopedics Corporation
57-2309
In Commercial Distribution

  • 10889981053116 ()

  • 13x12x9mm
57-2309

  • Vertebral body prosthesis, non-sterile
Zuma-C Implant, 13x12x8mm
Seaspine Orthopedics Corporation
57-2308
In Commercial Distribution

  • 10889981053109 ()

  • 13x12x8mm
57-2308

  • Vertebral body prosthesis, non-sterile
Zuma-C Implant, 13x12x7mm
Seaspine Orthopedics Corporation
57-2307
In Commercial Distribution

  • 10889981053093 ()

  • 13x12x7mm
57-2307

  • Vertebral body prosthesis, non-sterile
Zuma-C Implant, 13x12x6mm
Seaspine Orthopedics Corporation
57-2306
In Commercial Distribution

  • 10889981053086 ()

  • 13x12x6mm
57-2306

  • Vertebral body prosthesis, non-sterile
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
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