510(k) K253374
K253374 is an FDA 510(k) premarket notification submitted by Empirical Spine for the device "LimiFlex® Dynamic Sagittal Tether Instrument Set". The FDA issued a decision of Substantially Equivalent on Jun 16, 2026. The device falls under product code SGL (Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant), a Class II device regulated under 21 CFR 888.4520.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 16, 2026
- Date Received
- Sep 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant
- Device Class
- Class II
- Regulation Number
- 888.4520
- Review Panel
- OR
- Submission Type
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.