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510(k) Data Aggregation
K Number
K192473Device Name
Exsomed Wrist Plating System
Manufacturer
Exsomed Corporation
Date Cleared
2019-12-03
(84 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Exsomed Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Exsomed Wrist Plating System is intended for the repair of fractures and fusions of the hand and wrist.
Device Description
The Exsomed Wrist Plating System is a set of implantable metallic (Titanium Alloy) bone plates, locking and non-locking screws of various lengths. The system consists of a series of straight tubular plates of varying lengths as well as a 4-hole carpal fusion plate. Screws are provided for plate fixation in locking and non-locking versions and in Ø2.5 and Ø3.2mm diameters. All of the Implants are made from Titanium Alloy (Ti-6AL-4VELI) per ASTM F136 and are provided non-sterile.
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K Number
K183603Device Name
INnate Cannulated Screw System
Manufacturer
Exsomed Corporation
Date Cleared
2019-03-12
(76 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Exsomed Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ExsoMed INnate Cannulated Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Device Description
The ExsoMed INnate Cannulated Screw System is a stainless-steel bone screw system designed for bone fixation. The INnate system screws are cannulated and feature a headless design that allows for the screw to be countersunk below the surface of the bone. The system is provided sterile. The subject of this submission is the addition of a Ø3.6mm version of the INnate screw to the system to be offered in lengths of 25 to 55mm.
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