Cleared Traditional

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

K251472 · Inion OY · Neurology
Jul 2025
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K251472 is an FDA 510(k) clearance for the Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System, a Fastener, Plate, Cranioplasty (Class II — Special Controls, product code HBW), submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on July 11, 2025, 59 days after receiving the submission on May 13, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5360.

Submission Details

510(k) Number K251472 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2025
Decision Date July 11, 2025
Days to Decision 59 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBW — Fastener, Plate, Cranioplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5360

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