Class Class II
T2 Plus (K233806)
Description
T2 Plus by Osstem Implant Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233806
Clearance Date2024-09-06
Clearance TypeTraditional
Product CodeOAS
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233806
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. T2 Plus (K233806) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212303 | T2 | Osstem Implant Co., Ltd. | 2021 |
Trace the full predicate network for K233806
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.