INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE— 510(k) K090177
Substantially EquivalentInion OY
FDA 510(k) clearance K090177 for INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE, Substantially Equivalent on 2009-02-20. Applicant: Inion OY. Device class: 2.
Clearance details
- Applicant
- Inion OY
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tampere, FI
Recent devices under product code MQV
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 MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
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.