Clearance Summary
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE received FDA 510(k) clearance under submission number K823441, sponsored by Treace Medical, Inc.. 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 1982-12-03.
- Submission: K823441
- Applicant / Sponsor: Treace Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3450
- Decision date: 1982-12-03
Classification & Regulation
This clearance is catalogued under FDA product code LBM and 21 CFR 874.3450, within the Ear, Nose, Throat review panel as a Class II device.