Clearance Summary
LINK Embrace Shoulder System - Reverse Configuration received FDA 510(k) clearance under submission number K231445, sponsored by Waldemar Link GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-11-16.
- Submission: K231445
- Applicant / Sponsor: Waldemar Link GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3660
- Decision date: 2023-11-16
Classification & Regulation
This clearance is catalogued under FDA product code PHX and 21 CFR 888.3660, within the Orthopedic review panel as a Class II device.