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ETA — Replacement, Ossicular Prosthesis, Total Class II

FDA Device Classification

Classification Details

Product Code
ETA
Device Class
Class II
Regulation Number
874.3495
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241269med-el elektromedizinische gerätemXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO ToJanuary 17, 2025
K091187grace medicalGRACE DYNAMIC TORPSeptember 14, 2009
K083780audio technologiesSUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL0March 23, 2009
K043375karl storz endoscopyFISCH TITANIUM MIDDLE EAR PROSTHESESJanuary 24, 2005
K042503heinz kurz gmbh medizintechnikKURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MMOctober 1, 2004
K030492invotec internationalTITANIUM OSSICULAR REPLACMENT SYSTEMMarch 3, 2003
K002378gyrus entMODULAR PORP AND TORP MODEL TBDAugust 29, 2000
K001404mednet locatorGOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOAugust 8, 2000
K001406mednet locatorHA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESESAugust 8, 2000
K001902gyrus entBOJRAB UNIVERSAL LONG IMLANT, MODEL TBDJuly 10, 2000
K993583strykerZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEMNovember 10, 1999
K992138micromedicsMICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIESAugust 9, 1999
K990601gyrus entBOJRAB MICRO-TORP, MODEL 7014-5845March 31, 1999
K981088exmoor plasticsMILLS COLUMELLA PROSTHESISJune 5, 1998
K972735mednet locatorTOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)September 5, 1997
K963899exmoor plasticsCAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)August 22, 1997
K972585heinz kurz gmbh medizintechnikAERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIAugust 4, 1997
K955615misten medicalMISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESISDecember 22, 1995
K954518trebay medicalTREBAY TOTAL RECTANGULAR HEADOctober 27, 1995
K952549smith and nephew richardsRICHARDS TORPJuly 3, 1995