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FDA 510(k)

OsteoCentric Navigated Instruments System

K-Number: K250520 · 2025-10-27

ApplicantOsteocentric Technologies, Inc.
Decision Date2025-10-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OsteoCentric Navigated Instruments System is a medical device manufactured by Osteocentric Technologies, Inc.. It received FDA 510(k) clearance on 2025-10-27 under approval number K250520. 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 OsteoCentric Navigated Instruments System?

OsteoCentric Navigated Instruments System is a medical device that received FDA 510(k) clearance on 2025-10-27. It is manufactured by Osteocentric Technologies, Inc.. The 510(k) number is K250520.

When was OsteoCentric Navigated Instruments System approved by the FDA?

OsteoCentric Navigated Instruments System received FDA 510(k) clearance on 2025-10-27, under approval number K250520.

What company makes OsteoCentric Navigated Instruments System?

OsteoCentric Navigated Instruments System is manufactured by Osteocentric Technologies, Inc..

What is the FDA product code for OsteoCentric Navigated Instruments System?

The FDA product code for OsteoCentric Navigated Instruments System is OLO.

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Related PubMed Literature

PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026)

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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.

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