SternalPlate Expansion
K-Number: K243491 · 2024-12-11
ApplicantStryker Leibinger GmbH & Co KG
Decision Date2024-12-11
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SternalPlate Expansion is a medical device manufactured by Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2024-12-11 under approval number K243491. 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 SternalPlate Expansion?
SternalPlate Expansion is a medical device that received FDA 510(k) clearance on 2024-12-11. It is manufactured by Stryker Leibinger GmbH & Co KG. The 510(k) number is K243491.
When was SternalPlate Expansion approved by the FDA?
SternalPlate Expansion received FDA 510(k) clearance on 2024-12-11, under approval number K243491.
What company makes SternalPlate Expansion?
SternalPlate Expansion is manufactured by Stryker Leibinger GmbH & Co KG.
What is the FDA product code for SternalPlate Expansion?
The FDA product code for SternalPlate Expansion 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.