TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT

K954517 · Trebay Medical Corp. · ETB · Oct 27, 1995 · Ear, Nose, Throat

Device Facts

Record IDK954517
Device NameTREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT
ApplicantTrebay Medical Corp.
Product CodeETB · Ear, Nose, Throat
Decision DateOct 27, 1995
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 874.3450
Device ClassClass 2

Regulatory Classification

Identification

A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

Innolitics

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