CoreLink Navigation Instruments
510(k) K232116
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232116 | Date16 Aug 2023 | StatusActive |
Official records
- FDA 510(k) database K232116
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- FDA applicant
- Corelink, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
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.
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
- CD HORIZON® Spinal System RBT023201 by MEDTRONIC SOFAMOR DANEK, INC.
- Medtronic 9735501 by Medtronic Navigation Inc.
- Spineology Navigation Instruments by SPINEOLOGY INC.
- CD Horizon Spinal System Instruments for MAZOR X Stealth Edition by MEDTRONIC SOFAMOR DANEK, INC.
- 7D Surgical System Drill Guide by 7D Surgical, Inc.
- ERISMA® LP_NAVIGATED INSTRUMENTS 48710005 by Clariance, Inc.
- CUVIS-spine by CUREXO, Inc.
- Paradigm System by Proprio
- icotec Systems, Navigation Adapter 42-680N by icotec AG
- OMNIBotics NS-06752 by OMNIlife science, Inc.