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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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FBM-Osteo Foam Granules-Collagen Strip is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. FBM-Osteo Foam Granules-Collagen Strip is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.
BERKELEY ADVANCED BIOMATERIALS, LLC
FBO1-100X25-10
In Commercial Distribution

  • 00816125024940 ()
FBO1-100X25-10

  • Bone matrix implant, composite
FBM-Osteo Foam Granules-Collagen Strip is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. FBM-Osteo Foam Granules-Collagen Strip is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.
BERKELEY ADVANCED BIOMATERIALS, LLC
FBO1-90X22-07
In Commercial Distribution

  • 00816125024933 ()
FBO1-90X22-07

  • Bone matrix implant, composite
FBM-Osteo Foam Granules-Collagen Strip is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. FBM-Osteo Foam Granules-Collagen Strip is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.
BERKELEY ADVANCED BIOMATERIALS, LLC
FBO2-50X10-05
In Commercial Distribution

  • 00816125024926 ()
FBO2-50X10-05

  • Bone matrix implant, composite
FBM-Osteo Foam Granules-Collagen Strip is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. FBM-Osteo Foam Granules-Collagen Strip is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.
BERKELEY ADVANCED BIOMATERIALS, LLC
FBO1-50X10-02
In Commercial Distribution

  • 00816125024919 ()
FBO1-50X10-02

  • Bone matrix implant, composite
FBM-Osteo Foam Granules-Collagen Strip is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. FBM-Osteo Foam Granules-Collagen Strip is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.
BERKELEY ADVANCED BIOMATERIALS, LLC
FBO2-50X10-02
In Commercial Distribution

  • 00816125024902 ()
FBO2-50X10-02

  • Bone matrix implant, composite
FBM-Osteo Foam Granules-Collagen Strip is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. FBM-Osteo Foam Granules-Collagen Strip is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.
BERKELEY ADVANCED BIOMATERIALS, LLC
FBO1-50X10-01
In Commercial Distribution

  • 00816125024896 ()
FBO1-50X10-01

  • Bone matrix implant, composite
AlexiFuse Synthetic Foam Putty is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. AlexiFuse Synthetic Foam Putty is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.
BERKELEY ADVANCED BIOMATERIALS, LLC
AB-3454
In Commercial Distribution

  • 00816125024889 ()
AB-3454

  • Bone matrix implant, composite
AlexiFuse Synthetic Foam Putty is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. AlexiFuse Synthetic Foam Putty is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.
BERKELEY ADVANCED BIOMATERIALS, LLC
AB-3453
In Commercial Distribution

  • 00816125024872 ()
AB-3453

  • Bone matrix implant, composite
AlexiFuse Synthetic Foam Putty is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. AlexiFuse Synthetic Foam Putty is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.
BERKELEY ADVANCED BIOMATERIALS, LLC
AB-3452
In Commercial Distribution

  • 00816125024865 ()
AB-3452

  • Bone matrix implant, composite
AlexiFuse Synthetic Foam Putty is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite - 40% tricalcium phosphate resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. AlexiFuse Synthetic Foam Putty is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.
BERKELEY ADVANCED BIOMATERIALS, LLC
AB-3451
In Commercial Distribution

  • 00816125024858 ()
AB-3451

  • Bone matrix implant, composite
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