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FDA 510(k)

Exalta Proximal Tibia Plating System

K-Number: K261207 · 2026-06-12

ApplicantTyber Medical, LLC
Decision Date2026-06-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exalta Proximal Tibia 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 2026-06-12 under 510(k) number K261207. 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 Exalta Proximal Tibia Plating System?

Exalta Proximal Tibia Plating System is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Tyber Medical, LLC. The 510(k) number is K261207.

When did Exalta Proximal Tibia Plating System receive FDA 510(k) clearance?

Exalta Proximal Tibia Plating System received FDA 510(k) clearance on 2026-06-12, under 510(k) number K261207.

Who is the listed applicant for Exalta Proximal Tibia 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 Exalta Proximal Tibia Plating System?

The FDA product code for Exalta Proximal Tibia Plating System is HRS.

Other records listing Tyber Medical, LLC as applicant

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Related Devices (Code: HRS)

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.

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 TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KGK261351SALGINA 2.5mm Distal Radius SystemBonebridge AGK260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (LI.T.S. GmbH

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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