INION FREEDOMPIN— 510(k) K133932

Substantially Equivalent

Inion OY

FDA 510(k) clearance K133932 for INION FREEDOMPIN, Substantially Equivalent on 2014-04-11. Applicant: Inion OY.

Clearance details

Applicant: Inion OY
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2013-12-23
Decision date: 2014-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.