Dynamis Robotic Surgical System

GUDID 07649998256025

The Dynamis System is an integrated navigation-based robotic platform with real-time tracking capability for spine surgical procedures that include thoracic, lumbar, and sacral approaches. Dynamis is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding qualified surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans. The system is indicated for the placement of non-cervical spinal pedicle screws and is intended for use with any legally marketed spinal system that contains instruments meeting the criteria for use with the Dynacan end effectors of the Dynamis System.

LEM Surgical AG

Robotic surgical navigation system

• Primary Device ID: 07649998256025
• NIH Device Record Key: 7c77c339-30be-4518-a340-e87d9527dfbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynamis Robotic Surgical System
• Version Model Number: TPL0001
• Company DUNS: 480538984
• Company Name: LEM Surgical AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (844) 684-9483
• Email: pms@lemsurgical.com
• Phone: +1 (844) 684-9483
• Email: pms@lemsurgical.com
• Phone: +1 (844) 684-9483
• Email: pms@lemsurgical.com
• Phone: +1 (844) 684-9483
• Email: pms@lemsurgical.com
• Phone: +1 (844) 684-9483
• Email: pms@lemsurgical.com
• Phone: +1 (844) 684-9483
• Email: pms@lemsurgical.com
• Phone: +1 (844) 684-9483
• Email: pms@lemsurgical.com
• Phone: +1 (844) 684-9483
• Email: pms@lemsurgical.com
• Phone: +1 (844) 684-9483
• Email: pms@lemsurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07649998256025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243326

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-03-19
• Device Publish Date: 2025-10-14