Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System (K251472)
Description
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System by Inion OY, an FDA 510(k) cleared neurology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251472
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. Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System (K251472) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K052444 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | Inion , Ltd. | 2005 |
| K051341 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64... | Inion , Ltd. | 2005 |
| K033194 | INION CPS BABY 1.5 BIOABSORBABLE SYSTEM | Inion , Ltd. | 2003 |
Trace the full predicate network for K251472
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.