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510(k) Data Aggregation
K Number
K182609Device Name
Delphos Implants Rigid Fixation System
Manufacturer
Delphos Implants - Ind.Com. Importacao e Exportacao de
Date Cleared
2019-03-29
(189 days)
Product Code
JEY
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
Delphos Implants - Ind.Com. Importacao e Exportacao de
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
The Delphos Implants Rigid Fixation System implants are intended for single use only.
Device Description
The plates are manufactured in commercially pure titanium (ASTM F67 and ISO 5832-2) and the bone screws are manufactured from titanium alloy Ti-4Al-6V ELI (ASTM F136 and ISO 5832-3) and are available on different sizes, according with the site of the implantation and the extension of the fracture.
The devices are for single use, provided non-sterile, must be properly cleaned, disinfected and sterilized before use, according the recommendations provided on the Instructions for Use provided by Delphos Implants.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery and/or stomatology.
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