Cleared Traditional

K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES

K080070 · Grace Medical, Inc. · Ear, Nose, Throat
Apr 2008
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K080070 is an FDA 510(k) clearance for the K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES, a Prosthesis, Partial Ossicular Replacement (Class II — Special Controls, product code ETB), submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on April 17, 2008, 98 days after receiving the submission on January 10, 2008. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K080070 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2008
Decision Date April 17, 2008
Days to Decision 98 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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