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510(k) Data Aggregation
K Number
K223563Device Name
OsteoCNX
Manufacturer
Date Cleared
2023-01-25
(57 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Converg Engineering
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OsteoCNX Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). OsteoCNX Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. OsteoCNX Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), OsteoCNX Bone Graft Substitutes are resorbed with bone during the healing process
Device Description
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