gudid Primary ID: TPL0001-04

Dynamis Robotic Surgical System (UDI TPL0001-04)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Dynamis Robotic Surgical System (Model/Catalog Number: TPL0001-04) is a medical device manufactured by LEM Surgical AG. This product is indexed under FDA Product Code / Category Classification OLO within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: TPL0001-04
Product Code / EMDN: OLO
Device Name: The Dynamis Robotic Surgical System is an integrated navigation-based robotic platform with real-time tracking capability for spine surgical procedures that include cervical, thoracic, lumbar, and sacral approaches. The system is comprised of two computer-controlled robotic arms to support surgical robotic guidance, while a third robotic arm holds and controls the Scout navigation camera. All components are integrated into one physical cart located partially underneath the surgical table. The cart employs bilateral elevator mechanisms to deploy and fold the surgical robotic arms and secure them. This system functions in conjunction with different intraoperative imaging systems by data transfer of DICOM format images by USB and/or Direct LAN transfer for intraoperative planning. The system software is responsible for all motion control, navigation, data storage, user management, case management, and safety functions. The system establishes registration between the virtual patient (points on the patient DICOM images) and the physical patient (corresponding to the patients anatomy). The information of the plan, coupled with the registration, provides the necessary information to give visual assistance to the surgeon during the robotic alignment of qualified instruments or during free-hand navigation. Qualified instruments that are rigid, straight, round, and concentric are permitted for use through the Dynacan or used with the Dynatracker, given they pass the Instrument Setup process.The system also supports individual vertebra tracking to maintain alignment to vertebra specific trajectories by monitoring relative vertebral motion, as well as a stabilization workflow which provides additional control of vertebral motion during instrumentation.
Database Sync Date: 2026-08-09 09:07:23

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Dynamis Robotic Surgical System?

The registered manufacturer of record for Dynamis Robotic Surgical System is LEM Surgical AG.

What is the Primary UDI-DI identifier for Dynamis Robotic Surgical System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is TPL0001-04.

What classification code is assigned to this device?

This device is registered under product classification code OLO.

Similar Classification Devices (OLO)

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