Clearance Summary
PIEZOTOME M+, PIEZOTOME M+ Handpiece received FDA 510(k) clearance under submission number K163610, sponsored by Satalec-Acteon Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-05-19.
- Submission: K163610
- Applicant / Sponsor: Satalec-Acteon Group
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.4580
- Decision date: 2017-05-19
Classification & Regulation
This clearance is catalogued under FDA product code JDX and 21 CFR 888.4580, within the Orthopedic review panel as a Class II device.