Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Navigated Instruments

K-Number: K252742 · 2025-10-28

ApplicantTyber Medical, LLC
Decision Date2025-10-28
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2025-10-28 under 510(k) number K252742. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navigated Instruments?

Navigated Instruments is a medical device that received FDA 510(k) clearance on 2025-10-28. The listed applicant is Tyber Medical, LLC. The 510(k) number is K252742.

When did Navigated Instruments receive FDA 510(k) clearance?

Navigated Instruments received FDA 510(k) clearance on 2025-10-28, under 510(k) number K252742.

Who is the listed applicant for Navigated Instruments?

The FDA 510(k) record lists Tyber Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Navigated Instruments?

The FDA product code for Navigated Instruments is OLO.

Other records listing Tyber Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261207Exalta Proximal Tibia Plating SystemK260810Anteralign LS coverplateK261060Navigated LLIF Impactable TrackerK253042Tyber Medical Trauma ScrewK252901Tyber Medical Trauma ScrewK251361Tyber Medical Distal Radius Plating System

View all 27 devices →

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑