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510(k) K972585

Device
AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN
Applicant
HEINZ KURZ GMBH MEDIZINTECHNIK
510(k) number
K972585
Product code
ETA  
Decision
Substantially Equivalent (SESE)
Decision date
1997-08-04
Date received
1997-07-10
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
DAGMAR S MASER
Address
Tubinger Strasse 3 Dusslingen DE D-72144 D-72144

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
K083780SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2Audio Technologies S.R.L.2009-03-23
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

Legacy Summary#

summary

FDA Review#

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