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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Ventura NM Implant, 11mm x 32mm x 17mm
SEASPINE ORTHOPEDICS CORPORATION
33-6317
In Commercial Distribution

  • 10889981049874 ()

  • 11mm x 32mm x 17mm
33-6317

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 11mm x 32mm x 16mm
SEASPINE ORTHOPEDICS CORPORATION
33-6316
In Commercial Distribution

  • 10889981049867 ()

  • 11mm x 32mm x 16mm
33-6316

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 11mm x 32mm x 13mm
SEASPINE ORTHOPEDICS CORPORATION
33-6313
In Commercial Distribution

  • 10889981049836 ()

  • 11mm x 32mm x 13mm
33-6313

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 11mm x 32mm x 11mm
SEASPINE ORTHOPEDICS CORPORATION
33-6311
In Commercial Distribution

  • 10889981049812 ()

  • 11mm x 32mm x 11mm
33-6311

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 11mm x 32mm x 9mm
SEASPINE ORTHOPEDICS CORPORATION
33-6309
In Commercial Distribution

  • 10889981049799 ()

  • 11mm x 32mm x 9mm
33-6309

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 11mm x 32mm x 8mm
SEASPINE ORTHOPEDICS CORPORATION
33-6308
In Commercial Distribution

  • 10889981049782 ()

  • 11mm x 32mm x 8mm
33-6308

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 32mm x 17mm
SEASPINE ORTHOPEDICS CORPORATION
33-6217
In Commercial Distribution

  • 10889981049751 ()

  • 9mm x 32mm x 17mm
33-6217

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 32mm x 16mm
SEASPINE ORTHOPEDICS CORPORATION
33-6216
In Commercial Distribution

  • 10889981049744 ()

  • 9mm x 32mm x 16mm
33-6216

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 32mm x 15mm
SEASPINE ORTHOPEDICS CORPORATION
33-6215
In Commercial Distribution

  • 10889981049737 ()

  • 9mm x 32mm x 15mm
33-6215

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 32mm x 13mm
SEASPINE ORTHOPEDICS CORPORATION
33-6213
In Commercial Distribution

  • 10889981049713 ()

  • 9mm x 32mm x 13mm
33-6213

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 32mm x 12mm
SEASPINE ORTHOPEDICS CORPORATION
33-6212
In Commercial Distribution

  • 10889981049706 ()

  • 9mm x 32mm x 12mm
33-6212

  • Vertebral body prosthesis, non-sterile
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
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
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
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
15mm 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
98-2115
Not in Commercial Distribution

  • 10889981049539 ()

  • 15mm (22x10mm, 0°)
98-2115

  • 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
11mm 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
98-2111
Not in Commercial Distribution

  • 10889981049492 ()

  • 11mm (22x10mm, 0°)
98-2111

  • Orthopaedic implant inserter/extractor, reusable
10mm 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
98-2110
In Commercial Distribution

  • 10889981049485 ()

  • 10mm (22x10mm, 0°)
98-2110

  • Orthopaedic implant inserter/extractor, reusable
9mm 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
98-2109
Not in Commercial Distribution

  • 10889981049478 ()

  • 9mm (22x10mm, 0°)
98-2109

  • Orthopaedic implant inserter/extractor, reusable
12mm Wide Removal Tool. 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
98-2012
Not in Commercial Distribution

  • 10889981049447 ()

  • 12mm
98-2012

  • Orthopaedic implant inserter/extractor, reusable
Removal Tool. 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
98-2011
Not in Commercial Distribution

  • 10889981049430 ()
98-2011

  • Orthopaedic implant inserter/extractor, reusable
Expansion 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
98-2010
Not in Commercial Distribution

  • 10889981049423 ()

  • 10mm
98-2010

  • Orthopaedic implant inserter/extractor, reusable
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, 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, 26mm 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
82-2712
Not in Commercial Distribution

  • 10889981049324 ()

  • 26mm LG, 12-18mm HT, 12mm WD, 0°
82-2712

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm 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
82-2708
Not in Commercial Distribution

  • 10889981049300 ()

  • 26mm LG, 8-12mm HT, 12mm WD, 0°
82-2708

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm 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
82-2610
Not in Commercial Distribution

  • 10889981049287 ()

  • 26mm LG, 10-15mm HT, 10mm WD, 0°
82-2610

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm 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
82-2608
Not in Commercial Distribution

  • 10889981049270 ()

  • 26mm LG, 8-12mm HT, 10mm WD, 0°
82-2608

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm 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
82-2312
Not in Commercial Distribution

  • 10889981049263 ()

  • 22mm LG, 12-18mm HT, 12mm WD, 0°
82-2312

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm 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
82-2308
Not in Commercial Distribution

  • 10889981049249 ()

  • 22mm LG, 8-12mm HT, 12mm WD, 0°
82-2308

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm 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
82-2210
Not in Commercial Distribution

  • 10889981049225 ()

  • 22mm LG, 10-15mm HT, 10mm WD, 0°
82-2210

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 14.65mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2616
In Commercial Distribution

  • 10889981049201 ()

  • 30mm x 14.65mm
14-34-2616

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 13.33mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2614
Not in Commercial Distribution

  • 10889981049195 ()

  • 30mm x 13.33mm
14-34-2614

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 11.85mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2612
Not in Commercial Distribution

  • 10889981049188 ()

  • 30mm x 11.85mm
14-34-2612

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 14.65mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2216
Not in Commercial Distribution

  • 10889981049164 ()

  • 30mm x 14.65mm
14-34-2216

  • Vertebral body prosthesis, non-sterile
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