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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K251441
Device Name Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 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 Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
DZL  
Date Received05/09/2025
Decision Date 11/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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