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)

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 the device name listed in this FDA 510(k) record. The listed applicant is Osteocentric Technologies, Inc.. It received FDA 510(k) clearance on 2025-10-27 under 510(k) 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. The listed applicant is Osteocentric Technologies, Inc.. The 510(k) number is K250520.

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

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

Who is the listed applicant for OsteoCentric Navigated Instruments System?

The FDA 510(k) record lists Osteocentric Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Osteocentric Technologies, Inc. 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.

K251913OsteoCentric® UnifiMI® TCS Plating SystemK250494The OsteoCentric Bone Plate and Screw SystemK242691OsteoCentric Technologies Cannulated Fasteners and NutsK230242OsteoCentric Dental Implant SystemK230226Integrity-SI® Fusion SystemK230595OsteoCentric ACL Fixation System

View all 12 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.

↑