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510(k) Data Aggregation
K Number
K173385Device Name
Graft Delivery, DePuy Synthes
Manufacturer
Micromedics, Inc. (d/b/a Nordson MEDICAL)
Date Cleared
2017-11-30
(31 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Micromedics, Inc. (d/b/a Nordson MEDICAL)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Graft Preparation and Delivery Device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
Device Description
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