SGL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4520
- Medical specialty
- Orthopedic
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LimiFlex® Dynamic Sagittal Tether Instrument Set (K253374) | Empirical Spine | 2026-06-16 |
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