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510(k) Data Aggregation
K Number
K143100Device Name
NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta
Manufacturer
Cossington Ltd
Date Cleared
2015-03-05
(128 days)
Product Code
LOD, MBB
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
Cossington Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NP Cements Genta / NP Cement System Genta are intended for the fixation of prosthesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Device Description
The NP Cements Genta and NP Cements System Genta are PMMA, radiopaque bone cements, containing gentamicin and color additives to impart a green color, designed for the fixation of prosthesis to the living bone. The devices contain the same individual chemical constituents, but are supplied in different ways:
1. NP Cements Genta are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use.
2. NP Cements System Genta stores the powder and liquid components separately within a closed syringe-like device that serve as both mixing chamber and extrusion device. The device is provided with a vacuum tube and a cannula with the pusher rod. The product is packaged in a double blister, the external blister is sealed with a Tyyek lid, and then placed in an aluminum bag.
The devices are sold disposable and sterile. The NP Cements Genta are available in a low and high viscosity version. The NP Cements System Genta are also available in a low and high viscosity version.
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K Number
K143134Device Name
NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System
Manufacturer
Cossington Ltd
Date Cleared
2015-03-05
(125 days)
Product Code
LOD, PAN
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
Cossington Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NP Cements / NP Cements System are intended to be used for the fixation of artificial joint prostheses to the host bone.
Device Description
The NP Cements and NP Cements System are PMMA, radiopaque bone cements, containing color additives to impart a green color, designed for the fixation of prosthesis to the living bone. The devices contain the same individual chemical constituents, but are supplied in different ways:
1. NP Cements are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use.
2. NP Cements System stores the powder and liquid components separately within a closed syringe-like device that serve as both mixing chamber and extrusion device. The device is provided with a vacuum tube and a cannula with the pusher rod. The product is packaged in a double blister, the external blister is sealed with a Tyvek lid, and then placed in an aluminum bag.
The devices are sold disposable and sterile. The NP Cements are available in a low and high viscosity version. The NP Cements System are also available in a low and high viscosity version.
Ask a Question
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