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 a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2024-11-25 under approval 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. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K243162.
When was World Liner approved by the FDA?
World Liner received FDA 510(k) clearance on 2024-11-25, under approval number K243162.
What company makes World Liner?
World Liner is manufactured by Signature Orthopaedics Pty, Ltd..
What is the FDA product code for World Liner?
The FDA product code for World Liner is MEH.
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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.