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Vertebral bone filler, bioabsorbable

Definition
A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device is typically a sterile powder made of a calcium compound (e.g., calcium phosphate, calcium carbonate, hydroxyapatite), that is mixed with its sterile diluent prior to implantation, and designed to be implanted during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.
GUDID devices
26
Last updated
2026-03-17 18:51:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810131881429OsteoFlo HydroFiber - 1cc LabeledSurgentec, LLCHF-OSF-012026-03-09
00810131881436OsteoFlo HydroFiber - 3cc LabeledSurgentec, LLCHF-OSF-032026-03-09
00810131881443OsteoFlo HydroFiber - 6cc LabeledSurgentec, LLCHF-OSF-062026-03-09
00810131881450OsteoFlo HydroFiber - 12cc LabeledSurgentec, LLCHF-OSF-122026-03-09
00810131882013Synthetic Fiber Graft - 1ccSurgentec, LLCSHF-012026-03-09
00810131882020Synthetic Fiber Graft - 3ccSurgentec, LLCSHF-032026-03-09
00810131882037Synthetic Fiber Graft - 6ccSurgentec, LLCSHF-062026-03-09
00810131882044Synthetic Fiber Graft - 12ccSurgentec, LLCSHF-122026-03-09
00810131882136Synthetic Fiber Kit - 1ccSurgentec, LLCHFK-012026-03-09
00810131882143Synthetic Fiber Kit - 3ccSurgentec, LLCHFK-032026-03-09
00810131882150Synthetic Fiber Kit - 6ccSurgentec, LLCHFK-062026-03-09
00810131882167Synthetic Fiber Kit - 12ccSurgentec, LLCHFK-122026-03-09
00810131883751OsteoFlo Fiber Graft - 1ccSurgentec, LLCF-OHF-012026-03-09
00810131883768OsteoFlo Fiber Graft - 3ccSurgentec, LLCF-OHF-032026-03-09
00810131883775OsteoFlo Fiber Graft - 6ccSurgentec, LLCF-OHF-062026-03-09
00810131883782OsteoFlo Fiber Graft - 12ccSurgentec, LLCF-OHF-122026-03-09
00840085272271ASYNAstura MedicalJABB000252024-01-09
00840085272288ASYNAstura MedicalJABB000502024-01-09
00840085272295ASYNAstura MedicalJABB001002024-01-09
00840085272301AFIBERAstura MedicalJBAC000252024-01-09
00840085272318AFIBERAstura MedicalJBAC000502024-01-09
00840085272325AFIBERAstura MedicalJBAC001002024-01-09
00840085272332AFIBERAstura MedicalJBAC001502024-01-09
00840085272349AFIBERAstura MedicalJBCB000502024-01-09
00840085272356AFIBERAstura MedicalJBCB001002024-01-09
00840085272363AFIBERAstura MedicalJBCB502052024-01-09