Class Class II
Archer PSI System (K243509)
Description
Archer PSI System by 3D-Side, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243509
Clearance Date2025-05-12
Clearance TypeTraditional
Product CodeQHE
Regulation Number888.3660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243509
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. Archer PSI System (K243509) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190738 | MyShoulder Placement Guides | Medacta International S.A. | 2019 |
Trace the full predicate network for K243509
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.