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FDA 510(k)

Signature Osteosynthesis Plate System

K-Number: K241599 · 2025-02-06

ApplicantSignature Orthopaedic Pty , Ltd.
Decision Date2025-02-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Signature Osteosynthesis Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedic Pty , Ltd.. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K241599. 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 Signature Osteosynthesis Plate System?

Signature Osteosynthesis Plate System is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Signature Orthopaedic Pty , Ltd.. The 510(k) number is K241599.

When did Signature Osteosynthesis Plate System receive FDA 510(k) clearance?

Signature Osteosynthesis Plate System received FDA 510(k) clearance on 2025-02-06, under 510(k) number K241599.

Who is the listed applicant for Signature Osteosynthesis Plate System?

The FDA 510(k) record lists Signature Orthopaedic Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Signature Osteosynthesis Plate System?

The FDA product code for Signature Osteosynthesis Plate System is HRS.

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock 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 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.

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