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510(k) Data Aggregation
K Number
K140962Device Name
NORMED VARIO SUBTALAR SCREW
Manufacturer
Date Cleared
2014-07-03
(79 days)
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
NORMED NEDIZIN TECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Normed® Vario Subtalar Screw System is indicated for adult, children and adolescent patients.
The screws are intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Adult - additive subtalar alignment for flat foot.
Children - flexible flat foot treatment in children and adolescents.
Device Description
The Normed Vario Subtalar Screw is a conical, threaded cannulated screw. It is designed to be inserted into the sinus tarsi of the foot for subtalar arthoroereisis. It is made from medical grade titanium alloy, Ti-6Al-4V (ASTM F136). The implant is offered in 2 sizes: Small (10mm - 13mm) and Large (13mm -16mm). The implants are provided nonsterile and single-use only. The instruments are non-sterile and reusable.
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