← Product Code [ETB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB) · K010442

# KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 (K010442)

_Heinz Kurz · ETB · Mar 8, 2001 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K010442

## Device Facts

- **Applicant:** Heinz Kurz
- **Product Code:** [ETB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB.md)
- **Decision Date:** Mar 8, 2001
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 874.3450
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K010442](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K010442)

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