FDA.reportPublic FDA data

510(k) K010442

Device
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
Applicant
HEINZ KURZ
510(k) number
K010442
Product code
ETB  
Decision
Substantially Equivalent (SESE)
Decision date
2001-03-08
Date received
2001-02-14
Regulation
874.3450
Classification name
Prosthesis, Partial Ossicular Replacement
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAGMAR S MASER
Address
Amstel 320-I Amsterdam 1017ap NL

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ETB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);MED-EL Elektromedizinische Geräte GmbH2026-04-03
K260718mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)MED-EL Elektromedizinische Geräte GmbH2026-04-03
K241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis KitMED-EL Elektromedizinische Geräte GmbH2025-01-17
K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes ProsthesisMED-EL Elektromedizinische Geräte GmbH2025-01-17
K130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESISHeinz Kurz GmbH Medizintechnik2013-12-02
K112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESISHeinz Kurz GmbH Medizintechnik2013-02-08
K080070K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESESGrace Medical, Inc.2008-04-17
K063374NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOEGrace Medical, Inc.2006-12-06
K061853GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESESGrace Medical, Inc.2006-08-18
K060518PARTIAL OSSICULAR REPLACEMENT PROSTHESESGrace Medical, Inc.2006-06-28
K033554SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESISGyrus Ent LLC2003-11-24
K021479CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861Heinz Kurz GmbH Medizintechnik2002-05-21
K013573CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257Heinz Kurz GmbH Medizintechnik2001-11-09
K003214SMITH & NEPHEW PISTONSGyrus Ent LLC2000-10-31
K002737SMITH & NEPHEW PORPS & TORPSGyrus Ent LLC2000-10-12

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases