Clearance Summary
StealthFix Intraosseous Fixation System received FDA 510(k) clearance under submission number K232324, sponsored by Medartis, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-08-30.
- Submission: K232324
- Applicant / Sponsor: Medartis, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2023-08-30
Classification & Regulation
This clearance is catalogued under FDA product code JDR and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.