MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214— 510(k) K013546

Substantially Equivalent

Bionx Implants, Inc.

FDA 510(k) clearance K013546 for MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214, Substantially Equivalent on 2001-11-21. Applicant: Bionx Implants, Inc..

Clearance details

Applicant: Bionx Implants, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2001-10-24
Decision date: 2001-11-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampere, FI

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.