FDA 510(k)

The OsteoCentric Bone Plate and Screw System

K-Number: K250494 · 2025-03-18

Decision Date2025-03-18

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

The OsteoCentric Bone Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K250494. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The OsteoCentric Bone Plate and Screw System?

The OsteoCentric Bone Plate and Screw System is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is OsteoCentric Technologies. The 510(k) number is K250494.

When did The OsteoCentric Bone Plate and Screw System receive FDA 510(k) clearance?

The OsteoCentric Bone Plate and Screw System received FDA 510(k) clearance on 2025-03-18, under 510(k) number K250494.

Who is the listed applicant for The OsteoCentric Bone Plate and Screw System?

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

What is the FDA product code for The OsteoCentric Bone Plate and Screw System?

The FDA product code for The OsteoCentric Bone Plate and Screw System is HRS.

Other records listing OsteoCentric Technologies 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.

K250520OsteoCentric Navigated Instruments System K251913OsteoCentric® UnifiMI® TCS Plating System K242691OsteoCentric Technologies Cannulated Fasteners and Nuts K230242OsteoCentric Dental Implant System K230226Integrity-SI® Fusion System K230595OsteoCentric ACL Fixation System

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Related Devices (Code: HRS)

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip Technics K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip Technics K261054RibPlate SystemStryker Leibinger GmbH & Co KG

Official Source

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