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510(k) Data Aggregation
K Number
K161859Device Name
MagnetOs
Manufacturer
XPAND BIOTECHNOLOGY BV
Date Cleared
2017-02-24
(233 days)
Product Code
MQV, MOV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
XPAND BIOTECHNOLOGY BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MagnetOs is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs must be used with autograft as a bone graft extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs resorbs and is replaced with bone during the healing process.
Device Description
MagnetOs is a synthetic, osteoconductive and resorbable bone void filler for the repair of bony defects, containing 65-75% Tri-Calcium Phosphate (TCP, Ca3(PQ4)2) and 25-35% Hydroxyapatite (HA, Cas(PO4)3OH).
MagnetOs is gamma sterilized, comes in various sizes in granular or chip form and is sterile packaged for single use only.
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