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510(k) Data Aggregation
K Number
K030904Device Name
PALAMED
Manufacturer
Heraeus Medical Gmbh Technology
Date Cleared
2003-09-23
(183 days)
Product Code
LOD
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
Heraeus Medical Gmbh Technology
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Palamed* is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Device Description
Palamed® is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone.
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