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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Ventura NM Implant, 9mm x 28mm x 15mm
SEASPINE ORTHOPEDICS CORPORATION
33-6815
In Commercial Distribution

  • 10889981049973 ()

  • 9mm x 28mm x 15mm
33-6815

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 28mm x 14mm
SEASPINE ORTHOPEDICS CORPORATION
33-6814
In Commercial Distribution

  • 10889981049966 ()

  • 9mm x 28mm x 14mm
33-6814

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 28mm x 13mm
SEASPINE ORTHOPEDICS CORPORATION
33-6813
In Commercial Distribution

  • 10889981049959 ()

  • 9mm x 28mm x 13mm
33-6813

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 28mm x 12mm
SEASPINE ORTHOPEDICS CORPORATION
33-6812
In Commercial Distribution

  • 10889981049942 ()

  • 9mm x 28mm x 12mm
33-6812

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 9mm x 28mm x 9mm
SEASPINE ORTHOPEDICS CORPORATION
33-6809
In Commercial Distribution

  • 10889981049911 ()

  • 9mm x 28mm x 9mm
33-6809

  • Vertebral body prosthesis, non-sterile
Ventura NM Implant, 11mm x 32mm x 18mm
SEASPINE ORTHOPEDICS CORPORATION
33-6318
In Commercial Distribution

  • 10889981049881 ()

  • 11mm x 32mm x 18mm
33-6318

  • Vertebral body prosthesis, non-sterile
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 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
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
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
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
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
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
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
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
6mm Starter Trial. 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
98-2105
Not in Commercial Distribution

  • 10889981049454 ()

  • 6mm
98-2105

  • 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
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
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
98-2002
In Commercial Distribution

  • 10889981049416 ()
98-2002

  • Surgical drill guide, reusable
Inserter. 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
98-2000
Not in Commercial Distribution

  • 10889981049393 ()
98-2000

  • Orthopaedic implant inserter/extractor, reusable
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 10.5mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2610
Not in Commercial Distribution

  • 10889981049171 ()

  • 30mm x 10.5mm
14-34-2610

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 13.33mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2214
Not in Commercial Distribution

  • 10889981049157 ()

  • 30mm x 13.33mm
14-34-2214

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 30mm x 10.5mm
SEASPINE ORTHOPEDICS CORPORATION
14-34-2210
Not in Commercial Distribution

  • 10889981049133 ()

  • 30mm x 10.5mm
14-34-2210

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 26mm x 11.85mm
SEASPINE ORTHOPEDICS CORPORATION
14-33-2612
Not in Commercial Distribution

  • 10889981049126 ()

  • 26mm x 11.85mm
14-33-2612

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 26mm x 10.5mm
SEASPINE ORTHOPEDICS CORPORATION
14-33-2610
Not in Commercial Distribution

  • 10889981049119 ()

  • 26mm x 10.5mm
14-33-2610

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 26mm x 11.85mm
SEASPINE ORTHOPEDICS CORPORATION
14-33-2212
Not in Commercial Distribution

  • 10889981049102 ()

  • 26mm x 11.85mm
14-33-2212

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 26mm x 10.5mm
SEASPINE ORTHOPEDICS CORPORATION
14-33-2210
Not in Commercial Distribution

  • 10889981049096 ()

  • 26mm x 10.5mm
14-33-2210

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 22mm x 11.85mm
SEASPINE ORTHOPEDICS CORPORATION
14-32-2612
Not in Commercial Distribution

  • 10889981049089 ()

  • 22mm x 11.85mm
14-32-2612

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 22mm x 10.5mm
SEASPINE ORTHOPEDICS CORPORATION
14-32-2610
Not in Commercial Distribution

  • 10889981049072 ()

  • 22mm x 10.5mm
14-32-2610

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 22mm x 11.85mm
SEASPINE ORTHOPEDICS CORPORATION
14-32-2212
Not in Commercial Distribution

  • 10889981049065 ()

  • 22mm x 11.85mm
14-32-2212

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 22mm x 10.5mm
SEASPINE ORTHOPEDICS CORPORATION
14-32-2210
Not in Commercial Distribution

  • 10889981049058 ()

  • 22mm x 10.5mm
14-32-2210

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 18mm x 11.85mm
SEASPINE ORTHOPEDICS CORPORATION
14-31-2612
Not in Commercial Distribution

  • 10889981049041 ()

  • 18mm x 11.85mm
14-31-2612

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 18mm x 10.5mm
SEASPINE ORTHOPEDICS CORPORATION
14-31-2610
Not in Commercial Distribution

  • 10889981049034 ()

  • 18mm x 10.5mm
14-31-2610

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 18mm x 11.85mm
SEASPINE ORTHOPEDICS CORPORATION
14-31-2212
Not in Commercial Distribution

  • 10889981049027 ()

  • 18mm x 11.85mm
14-31-2212

  • Vertebral body prosthesis, non-sterile
Tapered Rectangular Spacer 18mm x 10.5mm
SEASPINE ORTHOPEDICS CORPORATION
14-31-2210
Not in Commercial Distribution

  • 10889981049010 ()

  • 18mm x 10.5mm
14-31-2210

  • Vertebral body prosthesis, non-sterile
26mm Trial, 10 Deg, 16 mm
SEASPINE ORTHOPEDICS CORPORATION
14-26-2616
In Commercial Distribution

  • 10889981049003 ()

  • 26mm , 10°, 16 mm
14-26-2616

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 10 Deg, 14 mm
SEASPINE ORTHOPEDICS CORPORATION
14-26-2614
In Commercial Distribution

  • 10889981048983 ()

  • 26mm , 10°, 14 mm
14-26-2614

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 10 Deg, 13 mm
SEASPINE ORTHOPEDICS CORPORATION
14-26-2213
In Commercial Distribution

  • 10889981048907 ()

  • 22mm , 10°, 13 mm
14-26-2213

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 10 Deg, 11 mm
SEASPINE ORTHOPEDICS CORPORATION
14-26-2211
In Commercial Distribution

  • 10889981048884 ()

  • 22mm , 10°, 11 mm
14-26-2211

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 5 Deg, 16 mm
SEASPINE ORTHOPEDICS CORPORATION
14-25-2616
In Commercial Distribution

  • 10889981048860 ()

  • 26mm , 5°, 16 mm
14-25-2616

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 5 Deg, 15 mm
SEASPINE ORTHOPEDICS CORPORATION
14-25-2615
In Commercial Distribution

  • 10889981048853 ()

  • 26mm , 5°, 15 mm
14-25-2615

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 5 Deg, 14 mm
SEASPINE ORTHOPEDICS CORPORATION
14-25-2614
In Commercial Distribution

  • 10889981048846 ()

  • 26mm , 5°, 14 mm
14-25-2614

  • Orthopaedic implant inserter/extractor, reusable
26mm Trial, 5 Deg, 13 mm
SEASPINE ORTHOPEDICS CORPORATION
14-25-2613
In Commercial Distribution

  • 10889981048839 ()

  • 26mm , 5°, 13 mm
14-25-2613

  • Orthopaedic implant inserter/extractor, reusable
22mm Trial, 5 Deg, 13 mm
SEASPINE ORTHOPEDICS CORPORATION
14-25-2213
In Commercial Distribution

  • 10889981048747 ()

  • 22mm , 5°, 13 mm
14-25-2213

  • Orthopaedic implant inserter/extractor, reusable
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