Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System— 510(k) K251441

Name: FDA 510(k) clearance K251441
Creator: U.S. Food and Drug Administration
Published: 2025-11-07

Substantially Equivalent

Inion OY

FDA 510(k) clearance K251441 for Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System, Substantially Equivalent on 2025-11-07. Applicant: Inion OY. Device class: 2.

Clearance details

Applicant: Inion OY
Product code: Code JEY
Device class: Class 2
Regulation: 21 CFR 872.4760
Advisory panel: Dental
Date received: 2025-05-09
Decision date: 2025-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

Download summary PDF View on FDA.gov ↗

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More clearances from Inion OY

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K251472 — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System2025-07-11
K203105 — Inion CompressOn Screw2021-01-13
K191764 — Inion BioRestore2019-07-31
K151360 — Inion Spinal Graft Containment System2015-10-06
K133932 — INION FREEDOMPIN2014-04-11

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.