MRI Universal
FDA 510(k) K240651 · Stryker Leibinger GmbH & Co KG
510(k) numberK240651
Submission
- Device name
- MRI Universal
- Applicant
- Stryker Leibinger GmbH & Co KG
Freiburg, DE - Received
- March 7, 2024
- Decision date
- July 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MRI Universal cleared by the FDA?
MRI Universal (K240651) received a 510(k) decision of Substantially Equivalent on July 12, 2024, 127 days after the submission was received.
What is the product code of K240651?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.