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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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The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatite (HA) and tri-calcium phosphate (TCP) granules, along with 45S5 bioactive glass granules. This implant utilizes biocompatible bovine fibrillar collagen and bioactive 45S5 glass particles. The granular composition includes 60 wt% HA and 40 wt% TCP, with the graft containing 20 wt% of 45S5 granules. This device serves as a scaffold to facilitate new bone growth. A sequence of surface reactions on the granules leads to the creation of a calcium phosphate layer that closely mimics the composition and structure of bone mineral hydroxyapatite. This layer, along with the HA-TCP granules, forms an osteoconductive scaffold that supports the growth of the patient’s new bone. As healing progresses, the graft material is gradually absorbed and transformed into new bone.
BERKELEY ADVANCED BIOMATERIALS, LLC
MSBG6540
In Commercial Distribution

  • 00816125024704 ()
MSBG6540

  • Bone matrix implant, synthetic, non-antimicrobial
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 SB008
In Commercial Distribution

  • 00816125023653 ()
M80 SB008

  • Bone matrix implant, synthetic, non-antimicrobial
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
XENCO MEDICAL LLC
XM-217-0110
In Commercial Distribution

  • B064XM21701101 ()


  • Bone-screw internal spinal fixation system rod
No Description
XENCO MEDICAL LLC
XM-217-0090
In Commercial Distribution

  • B064XM21700901 ()


  • Bone-screw internal spinal fixation system rod
No Description
XENCO MEDICAL LLC
XM-217-0080
In Commercial Distribution

  • B064XM21700801 ()


  • Bone-screw internal spinal fixation system rod
No Description
XENCO MEDICAL LLC
XM-217-0070
In Commercial Distribution

  • B064XM21700701 ()


  • Bone-screw internal spinal fixation system rod
No Description
XENCO MEDICAL LLC
XM-217-0060
In Commercial Distribution

  • B064XM21700601 ()


  • Bone-screw internal spinal fixation system rod
No Description
XENCO MEDICAL LLC
XM-217-0050
In Commercial Distribution

  • B064XM21700501 ()


  • Bone-screw internal spinal fixation system rod
No Description
XENCO MEDICAL LLC
XM-217-0040
In Commercial Distribution

  • B064XM21700401 ()


  • Bone-screw internal spinal fixation system rod
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