BIOCUFF,C, MODELS 236018, 236028, 236036— 510(k) K013057

Name: FDA 510(k) clearance K013057
Creator: U.S. Food and Drug Administration
Published: 2001-10-12

Substantially Equivalent

Bionx Implants, Inc.

FDA 510(k) clearance K013057 for BIOCUFF,C, MODELS 236018, 236028, 236036, Substantially Equivalent on 2001-10-12. Applicant: Bionx Implants, Inc.. Device class: 2.

Clearance details

Applicant: Bionx Implants, Inc.
Product code: Code MAI
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2001-09-12
Decision date: 2001-10-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampere, FI

Download summary PDF View on FDA.gov ↗

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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.