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 a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2025-10-28 under approval 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. It is manufactured by Tyber Medical, LLC. The 510(k) number is K252742.
When was Navigated Instruments approved by the FDA?
Navigated Instruments received FDA 510(k) clearance on 2025-10-28, under approval number K252742.
What company makes Navigated Instruments?
Navigated Instruments is manufactured by Tyber Medical, LLC.
What is the FDA product code for Navigated Instruments?
The FDA product code for Navigated Instruments is OLO.
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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.