Cleared Traditional

SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES

K904239 · Microbio-Medics, Inc. · Ear, Nose, Throat
Jun 1991
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K904239 is an FDA 510(k) clearance for the SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES, a Replacement, Ossicular Prosthesis, Total (Class II — Special Controls, product code ETA), submitted by Microbio-Medics, Inc. (Columbus, US). The FDA issued a Cleared decision on June 21, 1991, 281 days after receiving the submission on September 13, 1990. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3495.

Submission Details

510(k) Number K904239 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1990
Decision Date June 21, 1991
Days to Decision 281 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code ETA — Replacement, Ossicular Prosthesis, Total
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3495

Similar Devices — ETA Replacement, Ossicular Prosthesis, Total

All 37
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
K241269 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
GRACE DYNAMIC TORP
K091187 · Grace Medical, Inc. · Sep 2009
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
K083780 · Audio Technologies S.R.L. · Mar 2009
FISCH TITANIUM MIDDLE EAR PROSTHESES
K043375 · Karl Storz Endoscopy · Jan 2005
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
K042503 · Heinz Kurz GmbH Medizintechnik · Oct 2004
TITANIUM OSSICULAR REPLACMENT SYSTEM
K030492 · Invotec International, Inc. · Mar 2003