mGRIP Partial Prosthesis (0.75 mm) (58669) +10 more— 510(k) K260718

Clearance details

Device name as filed

mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)

Applicant

MED-EL Elektromedizinische Geräte GmbH

Product code

Code ETB

Device class

Class 2

Regulation

21 CFR 874.3450

Advisory panel

Ear, Nose, Throat

Date received

2026-03-05

Decision date

2026-04-03

Decision

Substantially Equivalent

Clearance type

Special

Location

Innsbruck, AT

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