ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM— 510(k) K080879

Substantially Equivalent

Bioretec, Ltd.

FDA 510(k) clearance K080879 for ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM, Substantially Equivalent on 2008-06-24. Applicant: Bioretec, Ltd..

Clearance details

Applicant: Bioretec, Ltd.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2008-03-31
Decision date: 2008-06-24
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.