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FDA 510(k)

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

K-Number: K251441 · 2025-11-07

ApplicantInion OY
Decision Date2025-11-07
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System is a medical device manufactured by Inion OY. It received FDA 510(k) clearance on 2025-11-07 under approval number K251441. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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 is a medical device that received FDA 510(k) clearance on 2025-11-07. It is manufactured by Inion OY. The 510(k) number is K251441.

When was Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System approved by the FDA?

Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System received FDA 510(k) clearance on 2025-11-07, under approval number K251441.

What company makes 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 is manufactured by Inion OY.

What is the FDA product code for Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System?

The FDA product code for Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System is JEY.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07079774 TrueLok Elevate PMCF Study RECRUITING

Other Devices by Inion OY

K191764Inion BioRestore K203105Inion CompressOn Screw K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System

Related Devices (Code: JEY)

K160363OPTIMUS CMF SYSTEMOsteonic Co., Ltd. K163579KLS Martin Individual Patient SolutionsKLS Martin L.P. K170773Stryker Universal MeshStryker K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker K170272TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV K171364MP LeFort I PlatesStryker

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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