510(k) Report

Devices descending from K130512

2 later devices reach Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…MED-EL Elektromedizinische Geräte GmbH20251—
+2K260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm)…MED-EL Elektromedizinische Geräte GmbH20260—