FDA.reportPublic FDA data

510(k) K241142

Device
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
Applicant
MED-EL Elektromedizinische Geräte GmbH
510(k) number
K241142
Product code
ETB
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-17
Date received
2024-04-25
Regulation
874.3450
Classification name
Prosthesis, Partial Ossicular Replacement
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Inés Román Santiago
Address
Fürstenweg 77a Innsbruck AT 6020 6020

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ETB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);MED-EL Elektromedizinische Geräte GmbH2026-04-03
K260718mGRIP 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)MED-EL Elektromedizinische Geräte GmbH2026-04-03
K241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis KitMED-EL Elektromedizinische Geräte GmbH2025-01-17
K130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESISHeinz Kurz GmbH Medizintechnik2013-12-02
K112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESISHeinz Kurz GmbH Medizintechnik2013-02-08
K080070K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESESGrace Medical, Inc.2008-04-17
K063374NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOEGrace Medical, Inc.2006-12-06
K061853GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESESGrace Medical, Inc.2006-08-18
K060518PARTIAL OSSICULAR REPLACEMENT PROSTHESESGrace Medical, Inc.2006-06-28
K033554SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESISGyrus Ent LLC2003-11-24
K021479CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik2002-05-21
K013573CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257Heinz Kurz GmbH Medizintechnik2001-11-09
K010442KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652Heinz Kurz2001-03-08
K003214SMITH & NEPHEW PISTONSGyrus Ent LLC2000-10-31
K002737SMITH & NEPHEW PORPS & TORPSGyrus Ent LLC2000-10-12