DeviceClearance

Product code SGL— Orthopedic

LimiFlex® Dynamic Sagittal Tether Instrument Set

Classification name
Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant
Device class
Class 2
Regulation
21 CFR 888.4520
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SGL under 21 CFR 888.4520, via openFDA

Market context for product code SGL

FDA has cleared 1 device under product code SGL, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SGL

Recent clearances under product code SGL

Data sourced from openFDA. This site is unofficial and independent of the FDA.