Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
by Medos International SARL EUDAMED510(k)
Active
510(k) K212756
Overview
This device is a Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set, classified as an orthopedic stereotaxic instrument. It is designed to assist surgeons in precise anatomical localization during spinal procedures, enabling accurate disc space preparation, discectomy, or bony resection. The set integrates with navigation systems to enhance surgical precision in spinal interventions.
The set is supplied as a reusable instrument kit, intended for use in sterile surgical environments. It is regulated under FDA 510(k) clearance (K212756) and meets MDR requirements. Compatible with spinal navigation systems, it is intended for use in orthopedic stereotaxic procedures, adhering to Class II – Special Controls standards. No MRI safety or single-use specifications are noted in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK212756 | Date5 May 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Medos International SARL
Questions
What types of spinal procedures can this navigation-ready instrument set assist with during surgery?
This Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set is designed to assist surgeons in precise anatomical localization for spinal procedures, specifically to enable accurate disc space preparation, discectomy (removal of disc material), or bony resection. The integration with navigation systems enhances precision during these interventions, making it particularly useful in orthopedic stereotaxic surgeries.
Is this instrument set reusable or single-use, and how should it be handled in a sterile surgical environment?
The set is explicitly described as a reusable instrument kit, meaning it is intended for repeated use in sterile surgical environments. Proper sterilization protocols must be followed between procedures to maintain safety and sterility, as it is not labeled for single-use.
What navigation systems is this set compatible with, and how does it improve surgical precision?
This set is designed to integrate with spinal navigation systems, though the specific brands or models are not detailed in the data. The inclusion of a universal navigation adaptor allows the instruments to align with these systems, enabling real-time anatomical localization and guidance during procedures like discectomy or bony resection, thereby improving precision and reducing surgical risks.
How is this device regulated, and what classification does it fall under in the FDA and MDR frameworks?
The device is regulated under FDA 510(k) clearance (K212756) and meets MDR (Medical Device Regulation) requirements. It is classified as a Class II – Special Controls orthopedic stereotaxic instrument, indicating it has additional regulatory oversight beyond general controls to ensure safety and effectiveness in spinal navigation-assisted procedures.
Are there any special storage requirements for this reusable instrument set?
While specific storage conditions (e.g., temperature, humidity) are not detailed in the data, as a reusable surgical instrument, it should be stored in a clean, dry environment to prevent contamination. After use, it must undergo proper sterilization before storage to comply with surgical best practices and maintain its functionality for subsequent procedures.