Stealth-Midas MR8 System
by Medtronic Powered Surgical Solutions
510(k) K183644
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183644 | Date22 May 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Stealth-Midas MR8 System is a high-speed drill designed for surgical procedures involving hard tissue and bone. As classified under product code OLO, it is intended for spinal and cranial applications, providing precise drilling and burring capabilities. This system integrates computer-assisted surgery features to enhance surgical precision and localization. Its design supports controlled tissue removal, reducing heat generation and improving visibility during procedures.
The device is supplied as a reusable surgical instrument, intended for use in operating rooms and sterile environments. It is regulated under FDA 510(k) clearance (K183644) and falls under the advisory jurisdiction of the Orthopaedic and Rehabilitation Devices Panel (OR). No specific MRI safety classification or sterility requirements are stated in the provided data. Storage and handling instructions are not detailed, but standard surgical instrument protocols should apply.
Other devices from Medtronic Powered Surgical Solutions
Questions
AI-generated answers, 1 Oct 2026
What surgical applications is the Stealth-Midas MR8 System designed for?
The Stealth-Midas MR8 System is specifically engineered for surgical procedures involving hard tissue and bone, with primary applications in spinal and cranial surgeries. Its design integrates computer-assisted surgery features to enhance precision and localization, making it ideal for procedures requiring meticulous control during drilling and burring. The system’s controlled tissue removal capability also helps minimize heat generation, which is critical in delicate operations where thermal damage to surrounding tissues must be avoided.
Is the Stealth-Midas MR8 System intended for single-use or reusable applications?
The Stealth-Midas MR8 System is supplied as a reusable surgical instrument. As a reusable device, it is intended for use in sterile operating room environments, where it can be cleaned, sterilized, and reused across multiple procedures. This aligns with standard protocols for surgical instruments designed for repeated use, ensuring cost-effectiveness and compliance with surgical hygiene standards.
Does the Stealth-Midas MR8 System have any specific sterility requirements?
The provided data does not specify any particular sterility requirements for the Stealth-Midas MR8 System. However, as a reusable surgical instrument, it must adhere to standard surgical instrument protocols for cleaning, sterilization, and maintenance to ensure safety and prevent contamination between uses. Clinicians should follow established guidelines for instrument reprocessing in their facility.
What distinguishes the Stealth-Midas MR8 System from other surgical drills?
The Stealth-Midas MR8 System stands out due to its integration of computer-assisted surgery features, which enhance precision and localization during spinal and cranial procedures. Unlike traditional drills, it is designed to provide controlled tissue removal, reducing heat generation and improving visibility—key factors in minimizing complications during delicate surgeries. Its high-speed capabilities further support efficient and accurate drilling in hard tissue applications.
How is the Stealth-Midas MR8 System regulated in the U.S.?
The Stealth-Midas MR8 System has received FDA 510(k) clearance under the product code OLO, with the clearance number K183644. This classification indicates that the device is deemed substantially equivalent to a legally marketed predicate device. The Orthopaedic and Rehabilitation Devices Panel (OR) oversees its regulatory jurisdiction, ensuring compliance with safety and performance standards for surgical instruments used in spinal and cranial applications.