Cleared Traditional

NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS

K130512 · Heinz Kurz GmbH Medizintechnik · Ear, Nose, Throat
Dec 2013
Decision
278d
Days
Class 2
Risk

About This 510(k) Submission

K130512 is an FDA 510(k) clearance for the NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS, a Prosthesis, Partial Ossicular Replacement (Class II — Special Controls, product code ETB), submitted by Heinz Kurz GmbH Medizintechnik (Dusslingen, DE). The FDA issued a Cleared decision on December 2, 2013, 278 days after receiving the submission on February 27, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K130512 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2013
Decision Date December 02, 2013
Days to Decision 278 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETB — Prosthesis, Partial Ossicular Replacement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3450

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