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FDA 510(k)

World Liner

K-Number: K243162 · 2024-11-25

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2024-11-25
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

World Liner is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K243162. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the World Liner?

World Liner is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K243162.

When did World Liner receive FDA 510(k) clearance?

World Liner received FDA 510(k) clearance on 2024-11-25, under 510(k) number K243162.

Who is the listed applicant for World Liner?

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

What is the FDA product code for World Liner?

The FDA product code for World Liner is MEH.

Other records listing Signature Orthopaedics Pty, Ltd. as applicant

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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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