BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD

• K Number: K001902
• Device Name: BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
• Manufacturer: GYRUS ENT L.L.C.
• Date Cleared: 2000-07-10 ( 18 days)
• Product Code: ETA
• Regulation Number: 874.3495

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 874.3495 Total ossicular replacement prosthesis.

(a)
Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.

Summary

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