Identifiers
- 510(k) Number
- K152747 FDA 510(k)
- FDA Product Code
- PDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.1820 FDA 510(k)
- Regulation Number
- 874.1820 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DSG Threaded Drill System is a neurosurgical drill designed for pilot hole drilling in pedicle screw placement. It provides real-time feedback to surgeons through visual and audible alerts, detecting changes in impedance at the drill tip to help avoid soft tissue contact and potential vertebral penetration. This feedback system enhances precision during spinal and skeletal implant procedures, particularly in anterior approaches and minimally invasive surgeries.
This system is supplied as a reusable medical device and is intended for use in both open and percutaneous (minimally invasive) surgical procedures. It is classified under FDA regulation number 874.1820 and holds a 510(k) clearance (K152747) for substantial equivalence. The device is not MRI-safe and requires proper storage to maintain functionality. Authorisations and regulatory compliance are managed by SpineGuard S.A., based in Vincennes, France.
Frequently asked questions
What types of surgical procedures is the DSG Threaded Drill System designed to assist with, and how does it enhance precision during these procedures?
The DSG Threaded Drill System is specifically designed for pilot hole drilling in pedicle screw placement during neurosurgical procedures. It is used in both open and minimally invasive (percutaneous) surgeries, particularly in spinal and skeletal implant procedures, including anterior approaches. The system enhances precision by providing real-time feedback through visual and audible alerts, which detect changes in impedance at the drill tip. This helps surgeons avoid soft tissue contact and potential vertebral penetration, improving accuracy and safety.
Is the DSG Threaded Drill System reusable, and what maintenance or storage requirements should be followed to ensure its functionality?
Yes, the DSG Threaded Drill System is supplied as a reusable medical device. To maintain its functionality, it must be stored properly and cleaned according to manufacturer guidelines. Since it is not MRI-safe, it should also be stored away from MRI environments to prevent interference or damage. Regular maintenance, as recommended by SpineGuard S.A., is essential to ensure optimal performance and longevity.
How does the feedback system in the DSG Threaded Drill System work, and what benefits does it provide during surgery?
The feedback system in the DSG Threaded Drill System uses real-time impedance monitoring at the drill tip. When the drill encounters changes in impedance—such as contact with soft tissue or bone—it triggers visual and audible alerts. This helps surgeons immediately recognize deviations from the intended drilling path, reducing the risk of complications like vertebral penetration or soft tissue damage. The system is particularly useful in minimally invasive surgeries where precision is critical.
What regulatory pathway was followed for the DSG Threaded Drill System, and who is responsible for its compliance?
The DSG Threaded Drill System underwent a traditional 510(k) review process through the FDA, achieving substantial equivalence under clearance number K152747. It is classified under FDA regulation number 874.1820 and falls under the Ear, Nose, and Throat (ENT) advisory committee category, though its actual use is in neurosurgical procedures. Regulatory compliance and authorizations are managed by SpineGuard S.A., based in Vincennes, France.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SpineGuard, Real Time Sensing DSG Technology, PediGuard, Spine, DSG Threaded Drill System (K152747) — FDA 510(k) | Innolitics, SpineGuard | Threaded PediGuard to Streamline Surgical Steps
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152747 | Class II | Active |
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Manufacturer
- Manufacturer
- SpineGuard.S.A
- FDA Applicant
- Spineguard S.A.
Sources (1)
- FDA 510(k) K152747 24 fields · synced Sep 20, 2026