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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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BiSyntek BA Glass Putty 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 and the 45S5 glass particles are bioactive. BiSyntek BA Glass Putty is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. BiSyntek BA Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8213-12P
In Commercial Distribution

  • 00816125026067 ()
ZS8213-12P

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass Putty 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 and the 45S5 glass particles are bioactive. BiSyntek BA Glass Putty is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. BiSyntek BA Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8213-10P
In Commercial Distribution

  • 00816125026050 ()
ZS8213-10P

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass Putty 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 and the 45S5 glass particles are bioactive. BiSyntek BA Glass Putty is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. BiSyntek BA Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8213-6P
In Commercial Distribution

  • 00816125026043 ()
ZS8213-6P

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass Putty 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 and the 45S5 glass particles are bioactive. BiSyntek BA Glass Putty is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. BiSyntek BA Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8213-5P
In Commercial Distribution

  • 00816125026036 ()
ZS8213-5P

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass Putty 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 and the 45S5 glass particles are bioactive. BiSyntek BA Glass Putty is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. BiSyntek BA Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8213-2P
In Commercial Distribution

  • 00816125026029 ()
ZS8213-2P

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass Putty 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 and the 45S5 glass particles are bioactive. BiSyntek BA Glass Putty is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. BiSyntek BA Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8213-1P
In Commercial Distribution

  • 00816125026012 ()
ZS8213-1P

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass 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 and the 45S5 glass particles are bioactive. BiSyntek BA Glass is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. BiSyntek BA Glass must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8-S510-5
In Commercial Distribution

  • 00816125026005 ()
ZS8-S510-5

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass 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 and the 45S5 glass particles are bioactive. BiSyntek BA Glass is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. BiSyntek BA Glass must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8-S510-2
In Commercial Distribution

  • 00816125025992 ()
ZS8-S510-2

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass 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 and the 45S5 glass particles are bioactive. BiSyntek BA Glass is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. BiSyntek BA Glass must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8-S125-15
In Commercial Distribution

  • 00816125025985 ()
ZS8-S125-15

  • Bone matrix implant, synthetic, non-antimicrobial
BiSyntek BA Glass 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 and the 45S5 glass particles are bioactive. BiSyntek BA Glass is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. BiSyntek BA Glass must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
ZS8-S125-12
In Commercial Distribution

  • 00816125025978 ()
ZS8-S125-12

  • Bone matrix implant, synthetic, non-antimicrobial
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