510(k) K240651
K240651 is an FDA 510(k) premarket notification submitted by Stryker Leibinger GmbH & Co KG for the device "MRI Universal". The FDA issued a decision of Substantially Equivalent on July 12, 2024. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Stryker Leibinger GmbH & Co KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2024
- Date Received
- March 7, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type