Clearance Summary
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 received FDA 510(k) clearance under submission number K201072, sponsored by Ensemble Orthopedics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-12-02.
- Submission: K201072
- Applicant / Sponsor: Ensemble Orthopedics, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3770
- Decision date: 2020-12-02
Classification & Regulation
This clearance is catalogued under FDA product code KYI and 21 CFR 888.3770, within the Orthopedic review panel as a Class II device.