Clearance Summary
LimiFlex® Dynamic Sagittal Tether Instrument Set received FDA 510(k) clearance under submission number K253374, sponsored by Empirical Spine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-06-16.
- Submission: K253374
- Applicant / Sponsor: Empirical Spine
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.4520
- Decision date: 2026-06-16
Classification & Regulation
This clearance is catalogued under FDA product code SGL and 21 CFR 888.4520, within the Orthopedic review panel as a Class II device.