INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000— 510(k) K051362

Substantially Equivalent

Inion OY

FDA 510(k) clearance K051362 for INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000, Substantially Equivalent on 2005-08-04. Applicant: Inion OY.

Clearance details

Applicant: Inion OY
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2005-05-25
Decision date: 2005-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

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Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.