Class Class II
Erisma® Lp Spinal Fixation System; Erisma® LP MIS (K241863)
Description
Erisma® Lp Spinal Fixation System; Erisma® LP MIS by Clariance, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241863
Clearance Date2024-07-24
Clearance TypeSpecial
Product CodeNKB
Regulation Number888.3070
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241863
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. Erisma® Lp Spinal Fixation System; Erisma® LP MIS (K241863) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation... | Clariance | 2024 |
| K162367 | Erisma® LP MIS | Clariance, Sas | 2016 |
Trace the full predicate network for K241863
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.