Cleared Traditional

GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES

K061853 · Grace Medical, Inc. · Ear, Nose, Throat
Aug 2006
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K061853 is an FDA 510(k) clearance for the GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL 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 August 18, 2006, 49 days after receiving the submission on June 30, 2006. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K061853 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2006
Decision Date August 18, 2006
Days to Decision 49 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

Similar Devices — ETB Prosthesis, Partial Ossicular Replacement

All 71
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
K241142 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
K241261 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
K130512 · Heinz Kurz GmbH Medizintechnik · Dec 2013
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
K112616 · Heinz Kurz GmbH Medizintechnik · Feb 2013
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K080070 · Grace Medical, Inc. · Apr 2008
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
K063374 · Grace Medical, Inc. · Dec 2006