Cleared Traditional

NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS

K112616 · Heinz Kurz GmbH Medizintechnik · Ear, Nose, Throat
Feb 2013
Decision
519d
Days
Class 2
Risk

About This 510(k) Submission

K112616 is an FDA 510(k) clearance for the NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS, a Prosthesis, Partial Ossicular Replacement (Class II — Special Controls, product code ETB), submitted by Heinz Kurz GmbH Medizintechnik (Amsterdam, NL). The FDA issued a Cleared decision on February 8, 2013, 519 days after receiving the submission on September 8, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K112616 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2011
Decision Date February 08, 2013
Days to Decision 519 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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