TITANIUM MIDDLE EAR PROSTHESES— 510(k) K002897

Clearance details

Applicant

Xomed, Inc.

Product code

Code ETB

Device class

Class 2

Regulation

21 CFR 874.3450

Advisory panel

Ear, Nose, Throat

Date received

2000-09-18

Decision date

2000-10-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Jacksonville, FL, US

• K260718 — mGRIP Partial Prosthesis (0.75 mm) (58669) +10 more2026-04-03
• K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more2026-04-03
• K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis2025-01-17
• K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit2025-01-17
• K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS2013-12-02

• K002395 — MODEL 30 CLASSIC PNEUMATONOMETER2000-12-11
• K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE2000-12-04
• K002828 — XPS NITRO SYSTEM2000-10-17
• K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES2000-06-09
• K001148 — MEROGEL OTOLOGIC PACK2000-06-03

• Z-2284-2013 — Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.Class II·Terminated·Medtronic Xomed, Inc.·20130823

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002897.