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ETB — Prosthesis, Partial Ossicular Replacement Class II

FDA Device Classification

Classification Details

Product Code
ETB
Device Class
Class II
Regulation Number
874.3450
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241261med-el elektromedizinische gerätemCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial ProsthesisJanuary 17, 2025
K241142med-el elektromedizinische gerätemAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIJanuary 17, 2025
K130512heinz kurz gmbh medizintechnikNITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PDecember 2, 2013
K112616heinz kurz gmbh medizintechnikNITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESISFebruary 8, 2013
K080070grace medicalK-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESESApril 17, 2008
K063374grace medicalNITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, December 6, 2006
K061853grace medicalGRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT August 18, 2006
K060518grace medicalPARTIAL OSSICULAR REPLACEMENT PROSTHESESJune 28, 2006
K033554gyrus entSMART OFFSET STAPES PISTON; SMART ISJ PROSTHESISNovember 24, 2003
K021479heinz kurz gmbh medizintechnikCLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861May 21, 2002
K013573heinz kurz gmbh medizintechnikCLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257November 9, 2001
K010442heinz kurzKURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 10March 8, 2001
K003214gyrus entSMITH & NEPHEW PISTONSOctober 31, 2000
K002737gyrus entSMITH & NEPHEW PORPS & TORPSOctober 12, 2000
K002897xomedTITANIUM MIDDLE EAR PROSTHESESOctober 11, 2000
K002464gyrus entSMITH & NEPHEW OFF-CENTERED PORPAugust 29, 2000
K002221heinz kurz gmbh medizintechnikKURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170August 9, 2000
K001142audio technologiesAUDIO TECHNOLOGIES S:R.1June 23, 2000
K000858gyrus entWEHRS INCUS-STAPESApril 3, 2000
K000256gyrus entCAP PORP, CAP TORPFebruary 11, 2000