Morgan Hill, CA, US · 1 510(k) clearances · 2 PMAs
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| SGL | Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant | Class II | Orthopedic | 1 | 2026-06-16 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-04-08 | P220031-S001 | LimiFlex Dynamic Sagittal Tether | Normal 180 Day Track No User Fee | SGK | — | — |
| 2026-02-12 | P220031 | LimiFlex Dynamic Sagittal Tether | Original | SGK | — | — |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-16 | K253374 | LimiFlex® Dynamic Sagittal Tether Instrument Set | SGL | Class II | Orthopedic |