FDA · official record K251441Substantially Equivalent

Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System

Name: Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System — FDA K251441
Creator: Inion OY
Keywords: Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System, Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System, K251441, JEY, FDA

United StatesJEYInion OY

Verified

Official record identity

FDA application number: K251441
Decision date: November 07, 2025
Published decision: Substantially Equivalent

Classification

Product code: JEY

Published parties

Applicant: Inion OY

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2025-05-09
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4760

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.