_Regulation · Permit_

# FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance)

Canonical ID: `760efd8c-f458-4f8e-a5c1-2ec73a3519c7`

- **Jurisdiction:** [United States](/locations/united-states.md) (id: `aa8b9c05-c836-4021-801f-59801970401e`)
- **Kind:** `permit`
- **Status (derived):** in_effect
- **Effective:** 2026-03-01

FDA granted an additional 510(k) clearance for the LEM Surgical Dynamis Robotic Surgical System, expanding its indications for minimally invasive procedures.

## Sources (1)

1. https://thespinemarketgroup.com/lem-surgical-announces-second-fda-510k-clearance-for-next-generation-humanoid-robotic-surgical-system/ · 2026-03-01

## Status history

- **in_effect** · 2026-03-01 · agent-recon
    - Initial ingestion

## Common questions

### What does FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance) cover?

FDA granted an additional 510(k) clearance for the LEM Surgical Dynamis Robotic Surgical System, expanding its indications for minimally invasive procedures.

### Where does FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance) apply?

FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance) is recorded as a permitting requirement applying in United States on the DEPLOY registry.

### When did FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance) take effect?

FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance) is recorded as effective March 1, 2026 on the DEPLOY registry.

### Is FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance) still in effect?

FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance) is currently in effect and applies to covered operators in the named jurisdiction.

### What types of robots does FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance) apply to?

FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance) is recorded as applying to surgical on the DEPLOY registry.

### Which robot models on the DEPLOY registry fall under FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance)?

8 robot models on the DEPLOY registry match the form-factor scope of FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance): ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.


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