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

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

1 summaries are archived here for direct download.