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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11mm Trial (22x10mm, 0 deg)
SEASPINE ORTHOPEDICS CORPORATION
98-2111
In Commercial Distribution

  • 10889981123710 ()

  • 11mm (22x10mm, 0 Deg)
98-2111

  • Orthopaedic implant inserter/extractor, reusable
10mm Trial (22x10mm, 0 deg)
SEASPINE ORTHOPEDICS CORPORATION
98-2110
In Commercial Distribution

  • 10889981123703 ()

  • 10mm (22x10mm, 0 Deg)
98-2110

  • Orthopaedic implant inserter/extractor, reusable
9mm Trial (22x10mm, 0 deg)
SEASPINE ORTHOPEDICS CORPORATION
98-2109
In Commercial Distribution

  • 10889981123697 ()

  • 9mm (22x10mm, 0 Deg)
98-2109

  • Orthopaedic implant inserter/extractor, reusable
8mm Trial (22x10mm, 0 deg)
SEASPINE ORTHOPEDICS CORPORATION
98-2108
In Commercial Distribution

  • 10889981123680 ()

  • 8mm (22x10mm, 0 Deg)
98-2108

  • Orthopaedic implant inserter/extractor, reusable
6mm Starter Trial
SEASPINE ORTHOPEDICS CORPORATION
98-2105
In Commercial Distribution

  • 10889981123673 ()

  • 6mm
98-2105

  • Orthopaedic implant inserter/extractor, reusable
12mm Wide Removal Tool
SEASPINE ORTHOPEDICS CORPORATION
98-2012
In Commercial Distribution

  • 10889981123666 ()

  • 12mm
98-2012

  • Orthopaedic implant inserter/extractor, reusable
Removal Tool
SEASPINE ORTHOPEDICS CORPORATION
98-2011
In Commercial Distribution

  • 10889981123659 ()
98-2011

  • Orthopaedic implant inserter/extractor, reusable
Expansion Driver
SEASPINE ORTHOPEDICS CORPORATION
98-2010
In Commercial Distribution

  • 10889981123642 ()
98-2010

  • Orthopaedic implant inserter/extractor, reusable
Expansion Driver
SEASPINE ORTHOPEDICS CORPORATION
98-2002
In Commercial Distribution

  • 10889981123635 ()
98-2002

  • Surgical drill guide, reusable
Inserter
SEASPINE ORTHOPEDICS CORPORATION
98-2001
In Commercial Distribution

  • 10889981123628 ()
98-2001

  • Orthopaedic implant inserter/extractor, reusable
Inserter
SEASPINE ORTHOPEDICS CORPORATION
98-2000
In Commercial Distribution

  • 10889981123611 ()
98-2000

  • Orthopaedic implant inserter/extractor, reusable
IMPLANT, 30mm LG, 12-18mm HT, 12mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-3112
In Commercial Distribution

  • 10889981123604 ()

  • 30mm LG, 12-18mm HT, 12mm WD, 0 Deg
82-3112

  • Vertebral body prosthesis, non-sterile
IMPLANT, 30mm LG, 10-15mm HT, 12mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-3110
In Commercial Distribution

  • 10889981123598 ()

  • 30mm LG, 10-15mm HT, 12mm WD, 0 Deg
82-3110

  • Vertebral body prosthesis, non-sterile
IMPLANT, 30mm LG, 8-12mm HT, 12mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-3108
In Commercial Distribution

  • 10889981123581 ()

  • 30mm LG, 8-12mm HT, 12mm WD, 0 Deg
82-3108

  • Vertebral body prosthesis, non-sterile
IMPLANT, 30mm LG, 12-18mm HT, 10mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-3012
In Commercial Distribution

  • 10889981123574 ()

  • 30mm LG, 12-18mm HT, 10mm WD, 0 Deg
82-3012

  • Vertebral body prosthesis, non-sterile
IMPLANT, 30mm LG, 10-15mm HT, 10mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-3010
In Commercial Distribution

  • 10889981123567 ()

  • 30mm LG, 10-15mm HT, 10mm WD, 0 Deg
82-3010

  • Vertebral body prosthesis, non-sterile
IMPLANT, 30mm LG, 8-12mm HT, 10mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-3008
In Commercial Distribution

  • 10889981123550 ()

  • 30mm LG, 8-12mm HT, 10mm WD, 0 Deg
82-3008

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm LG, 12-18mm HT, 12mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2712
In Commercial Distribution

  • 10889981123543 ()

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

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm LG, 10-15mm HT, 12mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2710
In Commercial Distribution

  • 10889981123536 ()

  • 26mm LG, 10-15mm HT, 12mm WD, 0 Deg
82-2710

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm LG, 8-12mm HT, 12mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2708
In Commercial Distribution

  • 10889981123529 ()

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

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm LG, 12-18mm HT, 10mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2612
In Commercial Distribution

  • 10889981123512 ()

  • 26mm LG, 12-18mm HT, 10mm WD, 0 Deg
82-2612

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm LG, 10-15mm HT, 10mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2610
In Commercial Distribution

  • 10889981123505 ()

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

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm LG, 8-12mm HT, 10mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2608
In Commercial Distribution

  • 10889981123499 ()

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

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2312
In Commercial Distribution

  • 10889981123482 ()

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

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2310
In Commercial Distribution

  • 10889981123475 ()

  • 22mm LG, 10-15mm HT, 12mm WD, 0 Deg
82-2310

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 8-12mm HT, 12mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2308
In Commercial Distribution

  • 10889981123468 ()

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

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 12-18mm HT, 10mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2212
In Commercial Distribution

  • 10889981123451 ()

  • 22mm LG, 12-18mm HT, 10mm WD, 0 Deg
82-2212

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 10-15mm HT, 10mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2210
In Commercial Distribution

  • 10889981123444 ()

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

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 8-12mm HT, 10mm WD, 0 DEG
SEASPINE ORTHOPEDICS CORPORATION
82-2208
In Commercial Distribution

  • 10889981123437 ()

  • 22mm LG, 8-12mm HT, 10mm WD, 0 Deg
82-2208

  • Vertebral body prosthesis, non-sterile
Expandable IBD Implants
SEASPINE ORTHOPEDICS CORPORATION
EXPIMP
In Commercial Distribution

  • 10889981123420 ()
EXPIMP

  • Instrument tray, reusable
Inserter
SEASPINE ORTHOPEDICS CORPORATION
98-2005
In Commercial Distribution

  • 10889981120764 ()
98-2005

  • Orthopaedic implant inserter/extractor, reusable
30mm Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
98-2923
In Commercial Distribution

  • 10889981123864 ()

  • 30mm
98-2923

  • Instrument tray, reusable
26mm Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
98-2922
In Commercial Distribution

  • 10889981123857 ()

  • 26mm
98-2922

  • Instrument tray, reusable
22mm Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
98-2921
In Commercial Distribution

  • 10889981123840 ()

  • 22mm
98-2921

  • Instrument tray, reusable
Implant Tray
SEASPINE ORTHOPEDICS CORPORATION
98-2920
In Commercial Distribution

  • 10889981123833 ()
98-2920

  • Instrument tray, reusable
SeaSpine Bi-Ostetic Cancellous Blocks is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. SeaSpine Bi-Ostetic Cancellous Blocks is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. SeaSpine Bi-Ostetic Cancellous Blocks is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. SeaSpine Bi-Ostetic Cancellous Blocks is an osteoconductive bone substitute shaped as blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks may be pressed into the void or into the surgical site by hand. The SeaSpine Bi-Ostetic Cancellous Blocks provide void filling material that acts as a temporary support medium. The blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. SeaSpine Bi-Ostetic Cancellous Blocks is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
SBiO-XYZ400606P
In Commercial Distribution

  • 00858418003966 ()
SBiO-XYZ400606P

  • Bone matrix implant, synthetic, non-antimicrobial
Pacifica 9x20mm, Lordotic Implants
SEASPINE ORTHOPEDICS CORPORATION
PAC920LIMP
In Commercial Distribution

  • 10889981162214 ()
PAC920LIMP

  • Instrument tray, reusable
Pacifica 11x24mm Implants
SEASPINE ORTHOPEDICS CORPORATION
PAC1124IMP
In Commercial Distribution

  • 10889981162207 ()
PAC1124IMP

  • Instrument tray, reusable
Pacifica 11x20mm Implants
SEASPINE ORTHOPEDICS CORPORATION
PAC1120IMP
In Commercial Distribution

  • 10889981162191 ()
PAC1120IMP

  • Instrument tray, reusable
Pacifica Implant 9mm x 20mm x 10mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
33-5210
In Commercial Distribution

  • 10889981031794 ()

  • 9mm x 20mm x 10mm
33-5210

  • Vertebral body prosthesis, non-sterile
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