510(k) Report

Devices descending from K990923

11 later devices reach Tubingen Titanium Prosthesis (TTP) Vario, Models Aerial 1004 010 & Bell 1002 010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total…MED-EL Elektromedizinische Geräte GmbH20251—
+1K241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and…MED-EL Elektromedizinische Geräte GmbH20251—
+1K061853Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesGrace Medical, Inc.20066—
+2K260718mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm)…MED-EL Elektromedizinische Geräte GmbH20260—
+2K260719mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691)…MED-EL Elektromedizinische Geräte GmbH20260—
+2K091187Grace Dynamic TorpGrace Medical, Inc.20090—
+2K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…Grace Medical, Inc.20064—
+3K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik20133—
+4K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik20132—
+5K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…MED-EL Elektromedizinische Geräte GmbH20251—
+6K260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm)…MED-EL Elektromedizinische Geräte GmbH20260—