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Regulation · Permit

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

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

Jurisdiction: United States · Effective 2026-03-01

Machine-readable surfaces

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.
Methodology: Unreviewed · 1 source (no primary) · last reviewed 2026-08-09

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Architectural position

Cohort: surgical

Sources by quality tier

1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance).

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