LimiFlex® Dynamic Sagittal Tether Instrument Set— 510(k) K253374
Substantially EquivalentEmpirical Spine
FDA 510(k) clearance K253374 for LimiFlex® Dynamic Sagittal Tether Instrument Set, Substantially Equivalent on 2026-06-16. Applicant: Empirical Spine. Device class: 2.
Summary
Empirical Spine's LimiFlex Dynamic Sagittal Tether Instrument Set is filed under SGL, manual instruments designed for use with a non-fusion spinous process tension band implant. The record doesn't list the instruments in the set.
Class II, 21 CFR 888.4520. Orthopedic is both the classification panel and the review panel. The submission was a Traditional 510(k).
Empirical Spine filed from Morgan Hill, California. The decision came 259 calendar days after receipt (September 30, 2025 to June 16, 2026).
Clearance details
- Applicant
- Empirical Spine
- Product code
- Product code SGL
- Device class
- Class 2
- Regulation
- 21 CFR 888.4520
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morgan Hill, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.