INION HEXALON BIODEGRADABLE ACL/PCL SCREW— 510(k) K071464
Substantially EquivalentInion OY
FDA 510(k) clearance K071464 for INION HEXALON BIODEGRADABLE ACL/PCL SCREW, Substantially Equivalent on 2007-08-03. Applicant: Inion OY. Device class: 2.
Clearance details
- Applicant
- Inion OY
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampere, FI
Recent devices under product code HWC
view allMore clearances from Inion OY
view all- K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
- K251472 — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
- K203105 — Inion CompressOn Screw
- K191764 — Inion BioRestore
- K151360 — Inion Spinal Graft Containment System
Adverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.