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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 a medical device manufactured by Signature Orthopaedic Pty , Ltd.. It received FDA 510(k) clearance on 2025-02-06 under approval 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. It is manufactured by Signature Orthopaedic Pty , Ltd.. The 510(k) number is K241599.

When was Signature Osteosynthesis Plate System approved by the FDA?

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

What company makes Signature Osteosynthesis Plate System?

Signature Osteosynthesis Plate System is manufactured by Signature Orthopaedic Pty , Ltd..

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

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

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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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