Smart Offset Stapes Piston; Smart Isj Prosthesis

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K033554 ↗

FDA Product Code

ETB

Models / Variants

Smart Offset Stapes Piston

Smart Isj Prosthesis

Device Class

Class II

Regulation

21 CFR Part 874.3450

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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