Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
FDA 510(k) clearance K251441 · decided 2025-11-07
Clearance details
- 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
- Decision
- Substantially Equivalent
- Date received
- 2025-05-09
- Decision date
- 2025-11-07
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tampere, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.