Class Class II
Anatomic Bone Plate (K221088)
Description
Anatomic Bone Plate by Double Medical Technology, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221088
Clearance Date2023-01-18
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221088
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. Anatomic Bone Plate (K221088) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K130108 | DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS | Xiamen Double Engine Medical Materi... | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | 2024 |
Trace the full predicate network for K221088
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.