NavLock Trackers, Robotic Reference Frame
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182104 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NavLock Trackers, Robotic Reference Frame is an orthopedic stereotaxic instrument classified under product code OLO. It is designed to enable navigation during spinal fusion and interbody procedures when used with Medtronic instruments on the MAZOR X Stealth Edition system.
The Robotic Reference Frame serves as an accessory to the MAZOR X Stealth Edition system. It is supplied by Medtronic Navigation and has received FDA 510(k) clearance with K-number K182104. The device is intended for use in specific spinal procedures utilizing compatible Medtronic systems.
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: NavLock Trackers, Robotic Reference Frame (K182104) - FDA 510 (k), NavLock Trackers, Robotic Reference Frame (K182104) — FDA 510(k ..., NavLock Trackers (K201327) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182104 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Navigation
Sources (1)
- FDA 510(k) K182104 24 fields · synced Sep 27, 2026