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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IMPLANT, 22mm 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
82-2208
Not in Commercial Distribution

  • 10889981049218 ()

  • 22mm LG, 8-12mm HT, 10mm WD, 0°
82-2208

  • Vertebral body prosthesis, non-sterile
LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 60mm X 10°
SEASPINE ORTHOPEDICS CORPORATION
31-60-0860-10
In Commercial Distribution

  • 10889981048167 ()

  • 8mm X 18mm X 60mm X 10°
31-60-0860-10

  • Spinal implant trial
LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 55mm X 10°
SEASPINE ORTHOPEDICS CORPORATION
31-60-0855-10
In Commercial Distribution

  • 10889981048150 ()

  • 8mm X 18mm X 55mm X 10°
31-60-0855-10

  • Spinal implant trial
LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 50mm X 10°
SEASPINE ORTHOPEDICS CORPORATION
31-60-0850-10
In Commercial Distribution

  • 10889981048143 ()

  • 8mm X 18mm X 50mm X 10°
31-60-0850-10

  • Spinal implant trial
LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 45mm X 10°
SEASPINE ORTHOPEDICS CORPORATION
31-60-0845-10
In Commercial Distribution

  • 10889981048136 ()

  • 8mm X 18mm X 45mm X 10°
31-60-0845-10

  • Spinal implant trial
LATERAL TRIAL, NARROW, LORDOTIC, 8mm X 18mm X 40mm X 10°
SEASPINE ORTHOPEDICS CORPORATION
31-60-0840-10
In Commercial Distribution

  • 10889981048129 ()

  • 8mm X 18mm X 40mm X 10°
31-60-0840-10

  • Spinal implant trial
Straight Inserter
SEASPINE ORTHOPEDICS CORPORATION
31-40-0294
In Commercial Distribution

  • 10889981048112 ()
31-40-0294

  • Orthopaedic implant inserter/extractor, reusable
Straight Lateral Inserter Draw Rod, 8mm Lordotic
SEASPINE ORTHOPEDICS CORPORATION
31-40-0282
In Commercial Distribution

  • 10889981048105 ()
31-40-0282

  • Orthopaedic implant inserter/extractor, reusable
Straight Lateral Inserter Draw Rod, Standard
SEASPINE ORTHOPEDICS CORPORATION
31-40-0281
In Commercial Distribution

  • 10889981048099 ()
31-40-0281

  • Orthopaedic implant inserter/extractor, reusable
Straight Lateral Inserter Shaft
SEASPINE ORTHOPEDICS CORPORATION
31-40-0280
In Commercial Distribution

  • 10889981048082 ()
31-40-0280

  • Orthopaedic implant inserter/extractor, reusable
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