FDA 510(k)

LimiFlex® Dynamic Sagittal Tether Instrument Set

K-Number: K253374 · 2026-06-16

Decision Date2026-06-16

Product CodeSGL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LimiFlex® Dynamic Sagittal Tether Instrument Set is the device name listed in this FDA 510(k) record. The listed applicant is Empirical Spine. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253374. The device is classified under product code SGL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LimiFlex® Dynamic Sagittal Tether Instrument Set?

LimiFlex® Dynamic Sagittal Tether Instrument Set is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Empirical Spine. The 510(k) number is K253374.

When did LimiFlex® Dynamic Sagittal Tether Instrument Set receive FDA 510(k) clearance?

LimiFlex® Dynamic Sagittal Tether Instrument Set received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253374.

Who is the listed applicant for LimiFlex® Dynamic Sagittal Tether Instrument Set?

The FDA 510(k) record lists Empirical Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LimiFlex® Dynamic Sagittal Tether Instrument Set?

The FDA product code for LimiFlex® Dynamic Sagittal Tether Instrument Set is SGL.

Other records listing Empirical Spine as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P220031Prosthesis, spinous process tension band implant

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.