Submission Details
| 510(k) Number | K240651 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 07, 2024 |
| Decision Date | July 12, 2024 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
MRI Universal
Jul 2024
Decision
127d
Days
Class 2
Risk
About This 510(k) Submission
K240651 is an FDA 510(k) clearance for the MRI Universal, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on July 12, 2024, 127 days after receiving the submission on March 7, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.
Device Classification
| Product Code | JEY — Plate, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4760 |
Manufacturer
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