mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (K241142)
Description
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis by Med-El Elektromedizinische Geräte GmbH, an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
FDA Database
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Predicate lineage for K241142
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (K241142) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K130512 | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PIST... | Heinz Kurz GmbH Medizintechnik | 2013 |
| K021479 | CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 | Heinz Kurz GmbH Medizintechnik | 2002 |
Trace the full predicate network for K241142
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.