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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Plate, Cranioplasty
510(k) Number K251472
Device Name Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
Applicant
Inion OY
Lääkärinkatu 2
Tampere,  FI FI-33520
Applicant Contact Hanne Kankaanpää
Correspondent
Inion OY
Lääkärinkatu 2
Tampere,  FI FI-33520
Correspondent Contact Hanne Kankaanpää
Regulation Number882.5360
Classification Product Code
HBW  
Date Received05/13/2025
Decision Date 07/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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