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510(k) Data Aggregation
K Number
K070864Device Name
BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER
Manufacturer
Date Cleared
2007-06-01
(65 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
BIOMET OSTEOBIOLOGICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BonePlast® QS Bone Void Filler is indicated to be injected into open voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BonePlast® QS Bone Void Filler is indicated only for bone voids or gaps that are not intrinsic to the bone structure (i.e., the extremities, spine and pelvis). The device is limited to be used in posterolateral spinal fusion procedures only.
Device Description
BonePlast OS Bone void filler is a sterile calcium suffate powder, which is supplied dry. When mixed with sterile setting solution intra-operatively, it becomes an injectable filling material for use in non-load bearing procedures. The filler is biogradable and resorbs in approximately eight to twelve weeks, depending on the defect size, based on animal studies.
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