Inion BioRestore— 510(k) K191764

Substantially Equivalent

Inion OY

FDA 510(k) clearance K191764 for Inion BioRestore, Substantially Equivalent on 2019-07-31. Applicant: Inion OY.

Clearance details

Applicant: Inion OY
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2019-07-01
Decision date: 2019-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampere, FI

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.