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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Disposable Dilator Kit Kit Contains: ML-0444S Insulated Dilator Set, 7, 12, & 15 MM, Sterile ML-0445 Stimulation Clip, 5-22mm, Single Use, 1/Each, Sterile
TEDAN SURGICAL INNOVATIONS, L.L.C.
ML-0459
In Commercial Distribution

  • 00851797006429 ()

  • Width: 15 Millimeter
  • Width: 12 Millimeter
  • Width: 7 Millimeter


  • Analytical non-scalp cutaneous lead
POSTERIOR WALL REMOVAL KERRISON, 20mm
Avalign Technologies, Inc.
00-5489-1520-99
In Commercial Distribution

  • 00190776149611 ()


  • Orthopaedic joint/limb rongeur
30mm Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
98-2923
In Commercial Distribution

  • 10889981123864 ()

  • 30mm
98-2923

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

  • 10889981123833 ()
98-2920

  • Instrument tray, reusable
Instrument Tray
SEASPINE ORTHOPEDICS CORPORATION
98-2900
In Commercial Distribution

  • 10889981123826 ()
98-2900

  • Instrument tray, reusable
Guide Hex Rod
SEASPINE ORTHOPEDICS CORPORATION
98-2205
In Commercial Distribution

  • 10889981123819 ()
98-2205

  • Surgical implant/trial-implant/sizer holder, reusable
Bone Funnel
SEASPINE ORTHOPEDICS CORPORATION
98-2202
In Commercial Distribution

  • 10889981123802 ()
98-2202

  • Bone graft funnel
Driver
SEASPINE ORTHOPEDICS CORPORATION
98-2201
In Commercial Distribution

  • 10889981123796 ()
98-2201

  • Surgical drill guide, reusable
18mm Trial (22x10mm, 0 deg)
SEASPINE ORTHOPEDICS CORPORATION
98-2118
In Commercial Distribution

  • 10889981123789 ()

  • 18mm (22x10mm, 0 Deg)
98-2118

  • Orthopaedic implant inserter/extractor, reusable
17mm Trial (22x10mm, 0 deg)
SEASPINE ORTHOPEDICS CORPORATION
98-2117
In Commercial Distribution

  • 10889981123772 ()

  • 17mm (22x10mm, 0 Deg)
98-2117

  • Orthopaedic implant inserter/extractor, reusable
16mm Trial (22x10mm, 0 deg)
SEASPINE ORTHOPEDICS CORPORATION
98-2116
In Commercial Distribution

  • 10889981123765 ()

  • 16mm (22x10mm, 0 Deg)
98-2116

  • Orthopaedic implant inserter/extractor, reusable
15mm Trial (22x10mm, 0 deg)
SEASPINE ORTHOPEDICS CORPORATION
98-2115
In Commercial Distribution

  • 10889981123758 ()

  • 15mm (22x10mm, 0 Deg)
98-2115

  • Orthopaedic implant inserter/extractor, reusable
14mm Trial (22x10mm, 0 deg)
SEASPINE ORTHOPEDICS CORPORATION
98-2114
In Commercial Distribution

  • 10889981123741 ()

  • 14mm (22x10mm, 0 Deg)
98-2114

  • Orthopaedic implant inserter/extractor, reusable
13mm Trial (22x10mm, 0 deg)
SEASPINE ORTHOPEDICS CORPORATION
98-2113
In Commercial Distribution

  • 10889981123734 ()

  • 13mm (22x10mm, 0 Deg)
98-2113

  • Orthopaedic implant inserter/extractor, reusable
12mm Trial (22x10mm, 0 deg)
SEASPINE ORTHOPEDICS CORPORATION
98-2112
In Commercial Distribution

  • 10889981123727 ()

  • 12mm (22x10mm, 0 Deg)
98-2112

  • Orthopaedic implant inserter/extractor, reusable
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
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
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
Newport 4.75 X 50mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4750
In Commercial Distribution

  • 10889981138813 ()

  • 4.75 X 50mm
61-4750

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 45mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4745
In Commercial Distribution

  • 10889981138806 ()

  • 4.75 X 45mm
61-4745

  • Bone-screw internal spinal fixation system, non-sterile
Newport 4.75 X 40mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4740
In Commercial Distribution

  • 10889981138790 ()

  • 4.75 X 40mm
61-4740

  • Bone-screw internal spinal fixation system, non-sterile
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