Clearance Summary
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS received FDA 510(k) clearance under submission number K112616, sponsored by Heinz Kurz GmbH Medizintechnik. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2013-02-08.
- Submission: K112616
- Applicant / Sponsor: Heinz Kurz GmbH Medizintechnik
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3450
- Decision date: 2013-02-08
Classification & Regulation
This clearance is catalogued under FDA product code ETB and 21 CFR 874.3450, within the Ear, Nose, Throat review panel as a Class II device.