FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
K Number: K251472
·
Decision Jul 11, 2025
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
6
Applicant Total
14
Review Days
59
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Basic Information
- Device Name
- Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
- K Number
- K251472
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5360
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inion OY
- Date Received
- May 13, 2025
- Decision Date
- July 11, 2025
- Product Code
- HBW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HBW | Fastener, Plate, Cranioplasty | FDA class 2 | Neurology |
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Other Clearances by Inion OY
| K Number | Device Name | ||
|---|---|---|---|
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Nov 7, 2025 | Substantially Equivalent |
| K203105 | Inion CompressOn Screw | Jan 13, 2021 | Substantially Equivalent |
| K191764 | Inion BioRestore | Jul 31, 2019 | Substantially Equivalent |
| K151360 | Inion Spinal Graft Containment System | Oct 6, 2015 | Unknown |
| K133932 | INION FREEDOMPIN | Apr 11, 2014 | Substantially Equivalent |
| K123672 | INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) | Feb 27, 2013 | Substantially Equivalent |
| K122890 | INION CPS ORBITAL PLATES | Jan 29, 2013 | Substantially Equivalent |
| K090177 | INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE | Feb 20, 2009 | Substantially Equivalent |
| K070998 | INION BIORESTORE | Oct 11, 2007 | Substantially Equivalent |
| K071464 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW | Aug 3, 2007 | Substantially Equivalent |