Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040312029

FEI Number

3040312029

Entity Name

LEM Surgical AG

City/State/Country

Bern, CH

Establishment Address

Morgenstrasse 136, Bern 3018, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LEM Surgical AG (Owner Number: 10093626)

Owner / Operator Contact Address

Morgenstrasse 136, Bern, CH-BE 3018, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243326

PMA Number

N/A

All Registered Proprietary Names

Dynamis Robotic Surgical System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-06-13

Official Correspondent

Yossi Bar

US Agent Details

Christopher Prentice Business: LEM Surgical, Inc. Email: chris.p@lemsurgical.com Phone: (727) 4538318

Related Public Records

Same Entity

LEM Surgical AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040312029. Last updated year: 2026. Please use registration number 3040312029 when referencing this establishment in official correspondence.