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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
No Description
Wishbone Medical, Inc.
TLK35050-US
In Commercial Distribution

  • B562TLK35050US0 ()
TLK35050

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Wishbone Medical, Inc.
TLK35050
In Commercial Distribution

  • B562TLK350500 ()
TLK35050

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Wishbone Medical, Inc.
TLK35045-US
In Commercial Distribution

  • B562TLK35045US0 ()
TLK35045

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Wishbone Medical, Inc.
TLK35045
In Commercial Distribution

  • B562TLK350450 ()
TLK35045

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Wishbone Medical, Inc.
TLK35040-US
In Commercial Distribution

  • B562TLK35040US0 ()
TLK35040

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Wishbone Medical, Inc.
TLK35040
In Commercial Distribution

  • B562TLK350400 ()
TLK35040

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Wishbone Medical, Inc.
TLK35038-US
In Commercial Distribution

  • B562TLK35038US0 ()
TLK35038

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Wishbone Medical, Inc.
TLK35038
In Commercial Distribution

  • B562TLK350380 ()
TLK35038

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Wishbone Medical, Inc.
TLK35036-US
In Commercial Distribution

  • B562TLK35036US0 ()
TLK35036

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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