FDA 510(k) Clearance: LEM Surgical Dynamis Robotic Surgical System (Second Clearance)
[in effect]United States · permit · permit
Jurisdiction
United States
Classification
permit
Status
in effect
Effective Date
Mar 1, 2026
Primary Sources
1 audited
Statutory Scope & Summary
FDA granted an additional 510(k) clearance for the LEM Surgical Dynamis Robotic Surgical System, expanding its indications for minimally invasive procedures.
Covered Sectors & Application Domains
Regulatory Analysis & Inquiries
6 entriesWhat 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.
Primary Sources & Legal Instruments
1 document- https://thespinemarketgroup.com/lem-surgical-announces-second-fda-510k-clearance-for-next-generation-humanoid-robotic-surgical-system/Official Source
https://thespinemarketgroup.com/lem-surgical-announces-second-fda-510k-clearance-for-next-generation-humanoid-robotic-surgical-system/