Cleared Traditional

LimiFlex® Dynamic Sagittal Tether Instrument Set (K253374) - FDA 510(k) Clearance

K253374 · Empirical Spine · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2026
Decision
259d
Days
-
Risk

K253374 is an FDA 510(k) clearance for the LimiFlex® Dynamic Sagittal Tether Instrument Set.

Submitted by Empirical Spine (Morgan Hill, US). The FDA issued a Cleared decision on June 16, 2026 after a review of 259 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Empirical Spine devices

Submission Details

510(k) Number K253374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date June 16, 2026
Days to Decision 259 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 122d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SGL
Device Class -