Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System— 510(k) K251472
Substantially EquivalentInion OY
FDA 510(k) clearance K251472 for Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System, Substantially Equivalent on 2025-07-11. Applicant: Inion OY. Device class: 2.
Clearance details
- Applicant
- Inion OY
- Product code
- Code HBW
- Device class
- Class 2
- Regulation
- 21 CFR 882.5360
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampere, FI
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More clearances from Inion OY
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