CoreLink Navigation Instruments
FDA 510(k) K230880 · Corelink, LLC
510(k) numberK230880
Submission
- Device name
- CoreLink Navigation Instruments
- Applicant
- Corelink, LLC
St. Louis, MO, US - Received
- March 30, 2023
- Decision date
- May 2, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Other 510(k)s with product code OLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | Remex Medical Corp. | 08/20/2026SE |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional | Suite 201, National Innovation Centre | 07/30/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | Spineart SA | 07/29/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | SurGenTec, LLC | 07/24/2026SE |
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | THINK Surgical, Inc. | 07/24/2026SE |
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | Ecential Robotics | 07/22/2026SE |
| K261852 | OTS HipOLO · Special | Ortoma AB | 07/01/2026SE |
| K253921 | VERTICALE® Navigation InstrumentsOLO · Traditional | Silony Medical GmbH | 06/26/2026SE |
| K260480 | VELYS Robotic-Assisted SolutionOLO · Traditional | Depuy Ireland UC | 06/25/2026SE |
| K260369 | Dynamis Robotic Surgical SystemOLO · Traditional | LEM Surgical AG | 06/20/2026SE |
More from LEM Surgical AG
| 510(k) | Device | Decision |
|---|---|---|
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…MAX · Traditional | 12/08/2023SE |
| K231494 | CoreLink Robotic Navigation InstrumentsOLO · Traditional | 10/27/2023SE |
| K232116 | CoreLink Navigation InstrumentsOLO · Special | 08/16/2023SE |
| K230329 | F3D Interbody SystemODP · Traditional | 06/06/2023SE |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant SystemOUR · Traditional | 03/21/2023SE |
| K221776 | NextGen Pedicle Screw SystemNKB · Traditional | 08/09/2022SE |
| K220973 | CoreLink Navigation InstrumentsOLO · Traditional | 06/01/2022SE |
| K211417 | F3D-C2 Cervical Stand-Alone SystemOVE · Traditional | 02/04/2022SE |
| K214059 | CoreLink Navigation InstrumentsOLO · Special | 01/19/2022SE |
| K212825 | CoreLink Navigation InstrumentsOLO · Traditional | 10/13/2021SE |
Questions and answers
When was CoreLink Navigation Instruments cleared by the FDA?
CoreLink Navigation Instruments (K230880) received a 510(k) decision of Substantially Equivalent on May 2, 2023, 33 days after the submission was received.
What is the product code of K230880?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.