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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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DLTA Driver, Extra Short AO
Seaspine Orthopedics Corporation
96-7042
In Commercial Distribution

  • 10889981100742 ()
96-7042

  • Orthopaedic implant driver
Drill for DIA 4.5mm Facet Screw
Seaspine Orthopedics Corporation
95-8004
In Commercial Distribution

  • 10889981100445 ()

  • 4.5mm
95-8004

  • Surgical screwdriver, reusable
3.5mm Cannulated Driver
Seaspine Orthopedics Corporation
95-8003
In Commercial Distribution

  • 10889981100438 ()

  • 3.5mm
95-8003

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
329700
In Commercial Distribution

  • 00880304350601 ()
329700

  • Fluted surgical drill bit, reusable
No Description
Biomet Orthopedics, LLC
329620
In Commercial Distribution

  • 00880304350496 ()
329620

  • Surgical screwdriver, reusable
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
98-2201
In Commercial Distribution

  • 10889981049577 ()
98-2201

  • Surgical drill guide, 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 inorganic 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
Sierra Extended Tab Screw, 04.5 x 50mm
Seaspine Orthopedics Corporation
51-4550
Not in Commercial Distribution

  • 10889981044022 ()

  • 4.5 Dia X 50mm
51-4550

  • Cannulated surgical drill bit, single-use
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
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