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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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Integra Expandable Interbody - 10889981049416

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

Sierra™ - 10889981044015

Sierra Extended Tab Screw, 04.5 x 45mm
Seaspine Orthopedics Corporation
51-4545
Not in Commercial Distribution

  • 10889981044015 ()

  • 4.5 Dia X 45mm
51-4545

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043995

Sierra Extended Tab Screw, 04.5 x 38mm
Seaspine Orthopedics Corporation
51-4538
Not in Commercial Distribution

  • 10889981043995 ()

  • 4.5 Dia X 38mm
51-4538

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043971

Sierra Extended Tab Screw, 04.5 x 34mm
Seaspine Orthopedics Corporation
51-4534
Not in Commercial Distribution

  • 10889981043971 ()

  • 4.5 Dia X 34mm
51-4534

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043957

Sierra Extended Tab Screw, 04.5 x 30mm
Seaspine Orthopedics Corporation
51-4530
Not in Commercial Distribution

  • 10889981043957 ()

  • 4.5 Dia X 30mm
51-4530

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043919

Sierra Extended Tab Screw, 04.5 x 22mm
Seaspine Orthopedics Corporation
51-4522
In Commercial Distribution

  • 10889981043919 ()

  • 4.5 Dia X 22mm
51-4522

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043896

Sierra Extended Tab Screw, 04.5 x 18mm
Seaspine Orthopedics Corporation
51-4518
In Commercial Distribution

  • 10889981043896 ()

  • 4.5 Dia X 18mm
51-4518

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043872

Sierra Extended Tab Screw, 04.5 x 14mm
Seaspine Orthopedics Corporation
51-4514
In Commercial Distribution

  • 10889981043872 ()

  • 4.5 Dia X 14mm
51-4514

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043858

Sierra Extended Tab Screw, 04.5 x 10mm
Seaspine Orthopedics Corporation
51-4510
Not in Commercial Distribution

  • 10889981043858 ()

  • 4.5 Dia X 10mm
51-4510

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043834

Sierra Extended Tab Screw, 04.0 x 40mm
Seaspine Orthopedics Corporation
51-4040
Not in Commercial Distribution

  • 10889981043834 ()

  • 4.0 Dia X 40mm
51-4040

  • Cannulated surgical drill bit, single-use
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