Cleared Traditional

K253374 - LimiFlex Dynamic Sagittal Tether Instru...

K253374 · Empirical Spine · Orthopedic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K253374

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.

SGL Device Classification - Class ,

Product Code SGL
Device Class -