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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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Vu aPod™ - L - 10889981117894

Angled Lateral Inserter Housing, LH
Seaspine Orthopedics Corporation
31-40-0290
In Commercial Distribution

  • 10889981117894 ()
31-40-0290

  • Orthopaedic implant driver

Vu aPod™ - L - 10889981117887

SPINPLATE Locker
Seaspine Orthopedics Corporation
31-40-0135
In Commercial Distribution

  • 10889981117887 ()
31-40-0135

  • Orthopaedic implant driver

RSR MD - 10889981117733

Dual Hex Driver
Seaspine Orthopedics Corporation
30-40-3001
In Commercial Distribution

  • 10889981117733 ()
30-40-3001

  • Orthopaedic implant driver

Steerable IBD - 10889981117382

Slap Hammer
Seaspine Orthopedics Corporation
29-40-0015
In Commercial Distribution

  • 10889981117382 ()
29-40-0015

  • Surgical mallet

Coral - 10889981117139

Locking Screw Final Tightener
Seaspine Orthopedics Corporation
28-40-0071
In Commercial Distribution

  • 10889981117139 ()
28-40-0071

  • Surgical screwdriver, reusable

Coral - 10889981116965

Q-Driver for Screw Extensions
Seaspine Orthopedics Corporation
28-40-0033
In Commercial Distribution

  • 10889981116965 ()
28-40-0033

  • Surgical screwdriver, reusable

Integra Expandable Interbody - 10889981049577

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

Integra Expandable Interbody - 10889981049423

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

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™ - 10889981044022

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
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