510(k) K253374

Device

LimiFlex® Dynamic Sagittal Tether Instrument Set

Applicant

Empirical Spine

510(k) number

K253374

Product code

SGL

Decision

Substantially Equivalent (SESE)

Decision date

2026-06-16

Date received

2025-09-30

Regulation

888.4520

Classification name

Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant

Medical specialty

Orthopedic

Review panel

Orthopedic

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N