FDA.reportPublic FDA data

510(k) K083780

Device
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
Applicant
Audio Technologies S.R.L.
510(k) number
K083780
Product code
ETA
Decision
Substantially Equivalent (SESE)
Decision date
2009-03-23
Date received
2008-12-19
Regulation
874.3495
Classification name
Replacement, Ossicular Prosthesis, Total
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
FRANCO BEONI
Address
Via Vallera, 42 Piacenza IT I-29100 I-29100

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ETA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260719mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50MED-EL Elektromedizinische Geräte GmbH2026-04-03
K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis KitMED-EL Elektromedizinische Geräte GmbH2025-01-17
K091187GRACE DYNAMIC TORPGrace Medical, Inc.2009-09-14
K043375FISCH TITANIUM MIDDLE EAR PROSTHESESKarl Storz Endoscopy2005-01-24
K042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik2004-10-01
K030492TITANIUM OSSICULAR REPLACMENT SYSTEMInvotec International, Inc.2003-03-03
K002378MODULAR PORP AND TORP MODEL TBDGyrus Ent LLC2000-08-29
K001406HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESESMednet Locator, Inc.2000-08-08
K001404GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTONMednet Locator, Inc.2000-08-08
K001902BOJRAB UNIVERSAL LONG IMLANT, MODEL TBDGyrus Ent LLC2000-07-10
K993583ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEMStryker Corp.1999-11-10
K992138MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIESMicromedics, Inc.1999-08-09
K990601BOJRAB MICRO-TORP, MODEL 7014-5845Gyrus Ent LLC1999-03-31
K981088MILLS COLUMELLA PROSTHESISExmoor Plastics , Ltd.1998-06-05
K972735TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)Mednet Locator, Inc.1997-09-05