Class Class II
EmbedMed (K221943)
Description
EmbedMed by 3D Lifeprints UK , Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221943
Clearance Date2023-02-01
Clearance TypeTraditional
Product CodePBF
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221943
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. EmbedMed (K221943) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212237 | 3D-Cut | 3D-Side S.A. | 2021 |
| K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | 2020 |
Trace the full predicate network for K221943
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.