FDA 510(k)

Tyber Medical Anatomical Plating System

K-Number: K242486 · 2025-03-19

Decision Date2025-03-19

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Tyber Medical Anatomical Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2025-03-19 under 510(k) number K242486. 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 Tyber Medical Anatomical Plating System?

Tyber Medical Anatomical Plating System is a medical device that received FDA 510(k) clearance on 2025-03-19. The listed applicant is Tyber Medical, LLC. The 510(k) number is K242486.

When did Tyber Medical Anatomical Plating System receive FDA 510(k) clearance?

Tyber Medical Anatomical Plating System received FDA 510(k) clearance on 2025-03-19, under 510(k) number K242486.

Who is the listed applicant for Tyber Medical Anatomical Plating System?

The FDA 510(k) record lists Tyber Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tyber Medical Anatomical Plating System?

The FDA product code for Tyber Medical Anatomical Plating System is HRS.

Other records listing Tyber Medical, LLC 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.

K261207Exalta Proximal Tibia Plating System K260810Anteralign LS coverplate K261060Navigated LLIF Impactable Tracker K253042Tyber Medical Trauma Screw K252901Tyber Medical Trauma Screw K252742Navigated Instruments

View all 27 devices →

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

View on FDA Database →

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