CoreLink Navigation Instruments
FDA 510(k)Class II (US FDA 510(k))
by Corelink Llc
Identifiers
- 510(k) Number
- K232116 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)
CoreLink Navigation Instruments are manual surgical instruments made from stainless steel that are used to interface with navigation systems for precise intra‑operative localization of anatomical structures. They are designed to work with the Medtronic StealthStation® Navigation System and are compatible with CoreLink pedicle screw and sacroiliac screw systems.
The instruments are supplied non‑sterile and are intended for reusable use. They are regulated under FDA 510(k) clearance (K232116, product code OLO) and were reviewed by the Neurology advisory committee. The devices are manufactured by CoreLink LLC in St. Louis, MO, United States.
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: CoreLink Surgical - Surgical Device Manufacturer, CoreLink Navigation Instruments by CoreLink, LLC | FDA 510 (k) Summary, CoreLink Navigation Instruments (K230880) — 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 | K232116 | Class II | Active |
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Manufacturer
- Manufacturer
- Corelink Llc
- FDA Applicant
- Corelink, LLC
Sources (1)
- FDA 510(k) K232116 24 fields · synced Sep 21, 2026