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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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Tribio™ Implant is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible. The 45S5 glass particles are bioactive. The device is available in the form of granules, strips, and putty. The composition of the granules is 60 wt% HA and 40 wt% TCP. The amount of 45S5 granules in the graft is 20 wt%. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer on the 45S5 granules and hydroxyapatite-tri-calcium phosphate granules provide an osteoconductive scaffold onto which the patient’s new bone will grow. During healing, the graft particulate is absorbed and remodeled into new bone.
BERKELEY ADVANCED BIOMATERIALS, LLC
M80 SB006
In Commercial Distribution

  • 00816125023646 ()
M80 SB006

  • Bone matrix implant, synthetic, non-antimicrobial
2.7 x 10.0 mm screws [7]
Nexus Cmf, L.L.C.
500423
Not in Commercial Distribution

  • M9575004230 ()


  • Craniofacial bone screw, non-bioabsorbable
2.7 x 8.0 mm screws [5]
Nexus Cmf, L.L.C.
500422
Not in Commercial Distribution

  • M9575004220 ()


  • Craniofacial bone screw, non-bioabsorbable
2.0 x 8.0 mm screws [5]
Nexus Cmf, L.L.C.
500421
Not in Commercial Distribution

  • M9575004210 ()


  • Craniofacial bone screw, non-bioabsorbable
2.0 x 6.0 mm screws [5]
Nexus Cmf, L.L.C.
500420
Not in Commercial Distribution

  • M9575004200 ()


  • Craniofacial bone screw, non-bioabsorbable
4.0 x 10 mm Simpler Threaded Grit Blasted Acid Etched Implants
Simpler Implant Solutions Inc
ST 3006
In Commercial Distribution

  • D780ST30060 ()

  • 4.0millimeters diameter x 10mm length r
ST 3006

  • Screw endosteal dental implant, two-piece
Simpli Simpler O Ring dental implant Grit Blasted Acid Etched One Piece
Simpler Implant Solutions Inc
SOS 3608
In Commercial Distribution

  • D780SOS36080 ()

  • 6.0 millimeters diameter x 8 mm length
SOS 3608

  • Screw endosteal dental implant, one-piece
Simpli Simpler O Ring dental implant Grit Blasted Acid Etched One Piece
Simpler Implant Solutions Inc
SOS 3515
In Commercial Distribution

  • D780SOS35150 ()
SOS 3515

  • Screw endosteal dental implant, one-piece
Simpli Simpler O Ring dental implant Grit Blasted Acid Etched One Piece
Simpler Implant Solutions Inc
SOS 3508
In Commercial Distribution

  • D780SOS35080 ()

  • 5.0milimeters diameter x 8mm length
SOS 3508

  • Screw endosteal dental implant, one-piece
Simpler Mini Grit Blasted Acid Etched Dental Implant
Simpler Implant Solutions Inc
SM3002
In Commercial Distribution

  • D780SM30020 ()
SM 3002

  • Screw endosteal dental implant, one-piece
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