SGL

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

Product code: SGL
Device name: Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant
Device class: Class 2
21 CFR: 21 CFR 888.4520
Medical specialty: Orthopedic
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1

FDA classification definition

The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process tension band implant for non-fusion use.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-06-16.

Number	Decision date	Applicant	Device name	Summary
K253374	2026-06-16	Empirical Spine	LimiFlex® Dynamic Sagittal Tether Instrument Set	PDF

1 summaries are archived here for direct download.

Official FDA classification page: SGL

Classification and pathway per current FDA publications. Data from openFDA (CC0).