BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736— 510(k) K001378

Substantially Equivalent

Bionx Implants, Inc.

FDA 510(k) clearance K001378 for BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736, Substantially Equivalent on 2000-07-28. Applicant: Bionx Implants, Inc..

Clearance details

Applicant: Bionx Implants, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2000-05-01
Decision date: 2000-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

Download summary PDF View on FDA.gov ↗

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.