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510(k) Data Aggregation
K Number
K152370Device Name
PRECICE Trauma Nail System
Manufacturer
Date Cleared
2015-12-22
(123 days)
Product Code
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
Ellipse Technologies Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
Device Description
The PRECICE Trauma Nail System is composed of the PRECICE Trauma Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC or ERC 2P). The Nail is available in various diameters, lengths and screw-hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE Trauma Nail is supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied pre-distracted by 10 mm (femur and tibia models), 15 mm and 20 mm (humeral model) to allow for compression fracture reduction techniques.
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