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510(k) Data Aggregation
K Number
K062260Device Name
OSTEOBOOST-BMA
Manufacturer
Date Cleared
2006-10-26
(83 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ORTHOS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Orthos-BMA™ kit is intended for use by suitable trained surgical personnel only.
The Orthos-BMA™ kit contains the apparatus required to harvest bone marrow and to combine the harvested marrow cells with an osteoconductive material such as a bone void filler for use in the treatment of osseous defects which can occur as a result of trauma or in skeletal defects created surgically.
Device Description
The Orthos-BMA™ kit contains the apparatus required for the collection of bone marrow using a minimally invasive aspiration technique.
The Orthos-BMA™ kit provides the surgeon with a convenient method of harvesting autologus bone marrow and combining it with their choice of osteoconductive material such as autogenous bone or a bone void filler such as ßGran synthetic osteoconductive scaffold.
The Orthos-BMA kit is supplied sterile for single patient use.
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