LimiFlex® Dynamic Sagittal Tether Instrument Set— 510(k) K253374

Name: FDA 510(k) clearance K253374
Creator: U.S. Food and Drug Administration
Published: 2026-06-16

Substantially Equivalent

Empirical Spine

FDA 510(k) clearance K253374 for LimiFlex® Dynamic Sagittal Tether Instrument Set, Substantially Equivalent on 2026-06-16. Applicant: Empirical Spine. Device class: 2.

Clearance details

Applicant: Empirical Spine
Product code: Code SGL
Device class: Class 2
Regulation: 21 CFR 888.4520
Advisory panel: Orthopedic
Date received: 2025-09-30
Decision date: 2026-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgan Hill, CA, US

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