Navigated Instruments
FDA 510(k) K252742 · Tyber Medical, LLC
510(k) numberK252742
Submission
- Device name
- Navigated Instruments
- Applicant
- Tyber Medical, LLC
Bethlehem, PA, US - Received
- August 28, 2025
- Decision date
- October 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K261207 | Exalta Proximal Tibia Plating SystemHRS · Traditional | 06/12/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | 06/10/2026SE |
| K261060 | Navigated LLIF Impactable TrackerOLO · Traditional | 05/29/2026SE |
| K253042 | Tyber Medical Trauma ScrewHWC · Traditional | 04/03/2026SE |
| K252901 | Tyber Medical Trauma ScrewHWC · Traditional | 12/31/2025SE |
| K251361 | Tyber Medical Distal Radius Plating SystemHRS · Traditional | 07/30/2025SE |
| K242486 | Tyber Medical Anatomical Plating SystemHRS · Traditional | 03/19/2025SE |
| K241218 | Tyber Medical Anatomical Plating SystemHRS · Special | 05/31/2024SE |
| K233423 | Tyber Medical Anatomical Plating System Line extension to the Mini-Frag SystemHRS · Traditional | 12/21/2023SE |
| K233017 | TM Plating SystemHRS · Traditional | 12/20/2023SE |
Questions and answers
When was Navigated Instruments cleared by the FDA?
Navigated Instruments (K252742) received a 510(k) decision of Substantially Equivalent on October 28, 2025, 61 days after the submission was received.
What is the product code of K252742?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.