FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K Number: K071464
·
Decision Aug 3, 2007
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
14
Review Days
66
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Basic Information
- Device Name
- INION HEXALON BIODEGRADABLE ACL/PCL SCREW
- K Number
- K071464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inion OY
- Date Received
- May 29, 2007
- Decision Date
- August 3, 2007
- Product Code
- HWC
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
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| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | Jul 11, 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 |