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510(k) Data Aggregation
K Number
K163226Device Name
EPIC Extremely Small Staple
Manufacturer
Epic Extremely, LLC
Date Cleared
2017-05-16
(180 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Epic Extremely, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EPIC Extremity Small Staple is indicated for use in fixation of bone fractures or bone reconstruction. Examples include:
* Wedge osteotomy of the first phalanx (Akin osteotomy)
* Treatment of hallux valgus in order to correct valgus or pronation of the first ray
* Wind swept toes
The Small Staple is intended for single use only
Device Description
The EPIC Extremity Small Staple will consist of one size and style, and instruments to assist in implanting the device.
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