FDA.report

510(k) K251441

Device
Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
Applicant
Inion OY
510(k) number
K251441
Product code
JEY
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-07
Date received
2025-05-09
Regulation
872.4760
Classification name
Plate, Bone
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Hanne Kankaanpää
Address
Lääkärinkatu 2 Tampere FI FI-33520 FI-33520

FDA Registration Numbers

Source Documents

510(k) summary PDF

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