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FDA 510(k)

OsteoCentric® UnifiMI® TCS Plating System

K-Number: K251913 · 2025-08-16

ApplicantOsteoCentric Technologies
Decision Date2025-08-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoCentric® UnifiMI® TCS Plating System is a medical device manufactured by OsteoCentric Technologies. It received FDA 510(k) clearance on 2025-08-16 under approval number K251913. 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 OsteoCentric® UnifiMI® TCS Plating System?

OsteoCentric® UnifiMI® TCS Plating System is a medical device that received FDA 510(k) clearance on 2025-08-16. It is manufactured by OsteoCentric Technologies. The 510(k) number is K251913.

When was OsteoCentric® UnifiMI® TCS Plating System approved by the FDA?

OsteoCentric® UnifiMI® TCS Plating System received FDA 510(k) clearance on 2025-08-16, under approval number K251913.

What company makes OsteoCentric® UnifiMI® TCS Plating System?

OsteoCentric® UnifiMI® TCS Plating System is manufactured by OsteoCentric Technologies.

What is the FDA product code for OsteoCentric® UnifiMI® TCS Plating System?

The FDA product code for OsteoCentric® UnifiMI® TCS Plating System is HRS.

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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