FDA 510(k) Applications for Medical Device Product Code "ETB"
(Prosthesis, Partial Ossicular Replacement)

FDA 510(k) Number Applicant Device Name Decision Date
K964798 ANTHONY D. PRESCOTT PARTIAL OSSICULAR REPLACEMENT PROSTHESIS 01/02/1997
K001142 AUDIO TECHNOLOGIES S.R.L. AUDIO TECHNOLOGIES S:R.1 06/23/2000
K981045 EXMOOR PLASTICS LTD. EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS 05/20/1998
K974365 EXMOOR PLASTICS LTD. MILLS INCUS HA SLEEVE 01/22/1998
K061853 Grace Medical, Inc. GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES 08/18/2006
K080070 Grace Medical, Inc. K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES 04/17/2008
K063374 Grace Medical, Inc. NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE 12/06/2006
K963752 Grace Medical, Inc. PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS 10/10/1996
K060518 Grace Medical, Inc. PARTIAL OSSICULAR REPLACEMENT PROSTHESES 06/28/2006
K972815 Grace Medical, Inc. PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT 10/08/1997
K991394 Grace Medical, Inc. STAPES PROSTHESES 05/18/1999
K000256 GYRUS ENT L.L.C. CAP PORP, CAP TORP 02/11/2000
K962564 GYRUS ENT L.L.C. RICHARDS TOTAL/PARTIAL PROSTHESIS 01/22/1997
K033554 GYRUS ENT L.L.C. SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS 11/24/2003
K002464 GYRUS ENT L.L.C. SMITH & NEPHEW OFF-CENTERED PORP 08/29/2000
K003214 GYRUS ENT L.L.C. SMITH & NEPHEW PISTONS 10/31/2000
K002737 GYRUS ENT L.L.C. SMITH & NEPHEW PORPS & TORPS 10/12/2000
K000858 GYRUS ENT L.L.C. WEHRS INCUS-STAPES 04/03/2000
K972492 HEINZ KURZ BELL PROSTHESIS (PARTIAL) 08/04/1997
K973356 HEINZ KURZ K-PISTON WITH BAND HOOK /ANGULAR PISTON 11/21/1997
K010442 HEINZ KURZ KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 03/08/2001
K990923 HEINZ KURZ TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 03/31/1999
K013573 HEINZ KURZ GMBH MEDIZINTECHNIK CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 11/09/2001
K021479 HEINZ KURZ GMBH MEDIZINTECHNIK CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 05/21/2002
K002221 HEINZ KURZ GMBH MEDIZINTECHNIK KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 08/09/2000
K112616 HEINZ KURZ GMBH MEDIZINTECHNIK NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS 02/08/2013
K130512 HEINZ KURZ GMBH MEDIZINTECHNIK NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS 12/02/2013
K992839 HEINZ KURZ GMBH MEDIZINTECHNIK SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE 09/16/1999
K972737 MEDNET LOCATOR, INC. CAUSSE PISTON 09/05/1997
K972734 MEDNET LOCATOR, INC. PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) 09/05/1997
K945105 MICROMED DEVELOPMENT CORP. POLY/PLATINUM WIRE PISTON 05/14/1996
K993234 MICROMEDICS, INC. MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS 11/10/1999
K964909 XOMED, INC. ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS 03/10/1997
K002897 XOMED, INC. TITANIUM MIDDLE EAR PROSTHESES 10/11/2000


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