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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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AlexiGlass Bioactive 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. AlexiGlass Bioactive 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. AlexiGlass Bioactive Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
AB-3503
In Commercial Distribution

  • 00816125025473 ()
AB-3503

  • Bone matrix implant, synthetic, non-antimicrobial
AlexiGlass Bioactive 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. AlexiGlass Bioactive 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. AlexiGlass Bioactive Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
AB-3502
In Commercial Distribution

  • 00816125025466 ()
AB-3502

  • Bone matrix implant, synthetic, non-antimicrobial
AlexiGlass Bioactive 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. AlexiGlass Bioactive 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. AlexiGlass Bioactive Glass Putty must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
AB-3501
In Commercial Distribution

  • 00816125025459 ()
AB-3501

  • Bone matrix implant, synthetic, non-antimicrobial
OBS Synthetic Bioactive Strip 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. OBS Synthetic Bioactive Strip 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. OBS Synthetic Bioactive Strip must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
OBS-25100BA
In Commercial Distribution

  • 00816125024452 ()
OBS-25100BA

  • Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
AA-12P
In Commercial Distribution

  • 00816125024346 ()
AA-12P

  • Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
AA-06P
In Commercial Distribution

  • 00816125024339 ()
AA-06P

  • Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
AA-02P
In Commercial Distribution

  • 00816125024322 ()
AA-02P

  • Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
AA-10P
In Commercial Distribution

  • 00816125023806 ()
AA-10P

  • Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
AA-05P
In Commercial Distribution

  • 00816125023790 ()
AA-05P

  • Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam 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. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
BERKELEY ADVANCED BIOMATERIALS, LLC
AA-01P
In Commercial Distribution

  • 00816125023783 ()
AA-01P

  • Bone matrix implant, synthetic, non-antimicrobial
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