Regulatory filing

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.

fda 510k · cleared · decided 2025-04-23

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing number: K243326
Decision date: 2025-04-23

Covered models (1)

Dynamis

Sources (1)

https://www.massdevice.com/lem-surgical-new-fda-clearance-surgical-robot/

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Identity

bf43e8d7-47b5-474c-bab8-d0ed5e428980