# K253374: LimiFlex® Dynamic Sagittal Tether Instrument Set

- Pathway: 510(k) (Traditional)
- Applicant: Empirical Spine
- Decided: Jun 16, 2026 after 259 days
- Product code: SGL (Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant)
- Device class: 2
- Regulation: 21 CFR 888.4520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K253118 (2025). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253118: Companion Spine DIAM™ Instrumentation, Companion Spine France (2025). Cleared while this submission was under review Summary page 5.

## Indications for use
The LimiFlex® Dynamic Sagittal Tether Instrument Set is intended to facilitate the implantation of the LimiFlex® Dynamic Sagittal Tether implant. The actual therapeutic effect is achieved by the LimiFlex® Dynamic Sagittal Tether implant.

Source page: https://510kreport.com/device/K253374
Methodology: https://510kreport.com/methodology