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

FDA 510(k) Number Applicant Device Name Decision Date
K083780 AUDIO TECHNOLOGIES S.R.L. SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 03/23/2009
K963899 EXMOOR PLASTICS LTD. CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) 08/22/1997
K981088 EXMOOR PLASTICS LTD. MILLS COLUMELLA PROSTHESIS 06/05/1998
K091187 Grace Medical, Inc. GRACE DYNAMIC TORP 09/14/2009
K990601 GYRUS ENT L.L.C. BOJRAB MICRO-TORP, MODEL 7014-5845 03/31/1999
K001902 GYRUS ENT L.L.C. BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD 07/10/2000
K002378 GYRUS ENT L.L.C. MODULAR PORP AND TORP MODEL TBD 08/29/2000
K972585 HEINZ KURZ GMBH MEDIZINTECHNIK AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN 08/04/1997
K042503 HEINZ KURZ GMBH MEDIZINTECHNIK KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM 10/01/2004
K030492 INVOTEC INTERNATIONAL, INC. TITANIUM OSSICULAR REPLACMENT SYSTEM 03/03/2003
K043375 KARL STORZ ENDOSCOPY FISCH TITANIUM MIDDLE EAR PROSTHESES 01/24/2005
K001404 MEDNET LOCATOR, INC. GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON 08/08/2000
K001406 MEDNET LOCATOR, INC. HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES 08/08/2000
K972735 MEDNET LOCATOR, INC. TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) 09/05/1997
K992138 MICROMEDICS, INC. MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES 08/09/1999
K993583 STRYKER CORP. ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM 11/10/1999


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