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510(k) K251441

Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System by Inion OY — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2025
Date Received
May 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Inion OY

  • K251472 — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsor (July 11, 2025)
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  • K191764 — Inion BioRestore (July 31, 2019)
  • K151360 — Inion Spinal Graft Containment System (October 6, 2015)
  • K133932 — INION FREEDOMPIN (April 11, 2014)
  • K123672 — INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) (February 27, 2013)
  • K122890 — INION CPS ORBITAL PLATES (January 29, 2013)
  • K090177 — INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE (February 20, 2009)
  • K071810 — INION SPINAL GRAFT CONTAINMENT SYSTEM (July 11, 2008)
  • K070998 — INION BIORESTORE (October 11, 2007)

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