BIORETEC ACTIVASCREW INTERFERENCE— 510(k) K130716

Substantially Equivalent

Bioretec, Ltd.

FDA 510(k) clearance K130716 for BIORETEC ACTIVASCREW INTERFERENCE, Substantially Equivalent on 2013-08-28. Applicant: Bioretec, Ltd..

Clearance details

Applicant: Bioretec, Ltd.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2013-03-15
Decision date: 2013-08-28
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.