Cleared Traditional

NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE

K063374 · Grace Medical, Inc. · Ear, Nose, Throat
Dec 2006
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K063374 is an FDA 510(k) clearance for the NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE, 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 December 6, 2006, 28 days after receiving the submission on November 8, 2006. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K063374 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2006
Decision Date December 06, 2006
Days to Decision 28 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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