# K243326 (us_fda)

LEM Surgical Dynamis robotic surgical system FDA 510(k) clearance. Integrated navigation-based robotic platform with real-time tracking for spine surgical procedures. Second clearance adds individual vertebra tracking, stabilization, and cervical indications.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Filing number: K243326
- Decision date: 2025-04-23

## Covered models (1)

- [Dynamis](/models/lem-surgical-dynamis.md)

## Sources (1)

- [https://www.massdevice.com/lem-surgical-new-fda-clearance-surgical-robot/](https://www.massdevice.com/lem-surgical-new-fda-clearance-surgical-robot/)

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