Class Class II
MRI Universal (K240651)
Description
MRI Universal by Stryker Leibinger GmbH & Co KG, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240651
Clearance Date2024-07-12
Clearance TypeTraditional
Product CodeJEY
Regulation Number872.4760
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240651
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. MRI Universal (K240651) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker Leibinger GmbH & Co KG | 2023 |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | 2022 |
| K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screws | Stryker | 2017 |
| K171364 | MP LeFort I Plates | Stryker | 2017 |
| K133461 | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM | Stryker | 2014 |
| K122313 | STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM | Stryker | 2012 |
| K050535 | STRYKER MMF SCREW | Stryker Instruments | 2005 |
Trace the full predicate network for K240651
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.